Independent Feedback On Components

Component code	feedback	Supplied by	Date
1100	FDA posting: Ossur voluntary recall - Some units of the Total Knee (1100, 1900, 2000, 2100) device may contain faulty pins based in the axis of the knee. http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html	RehabTech	06/04/2006
1100	We have gone through all the TGA requirements and notifiied affected customers. For further info see http://www.ossur.com/template110.asp?PageID=2275.	Ossur (Australia)	11/04/2006
1900	FDA posting: Ossur voluntary recall - Some units of the Total Knee (1100, 1900, 2000, 2100) device may contain faulty pins based in the axis of the knee. http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html	RehabTech	06/04/2006
1900	We have gone through all the TGA requirements and notifiied affected customers. For further info see http://www.ossur.com/template110.asp?PageID=2275.	Ossur (Australia)	11/04/2006
2000	FDA posting: Ossur voluntary recall - Some units of the Total Knee (1100, 1900, 2000, 2100) device may contain faulty pins based in the axis of the knee. http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html	RehabTech	06/04/2006
2000	We have gone through all the TGA requirements and notifiied affected customers. For further info see http://www.ossur.com/template110.asp?PageID=2275.	Ossur (Australia)	11/04/2006
2100	FDA posting: Ossur voluntary recall - Some units of the Total Knee (1100, 1900, 2000, 2100) device may contain faulty pins based in the axis of the knee. http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html	RehabTech	06/04/2006
2100	We have gone through all the TGA requirements and notifiied affected customers. For further info see http://www.ossur.com/template110.asp?PageID=2275.	Ossur (Australia)	11/04/2006
339008	Amputees above 90 Kg who are active walkers. The upper housing should be replaced with a new housing and the alignment access slot positioned on the medial side. Refer to MDA SN 1999(09) or Endolite Technical Bulletin No.10. Not to be used with Bilateral amputees of all weights. If fitted to such amputees it should be replaced. Refer to MDA SN 2000(16) or Endolite Technical Bulletin No.12.	MDA	27/04/1999
339009	Amputees above 100 Kg who are active walkers or amputees above 90 Kg who are sports participants. The upper housing should be replaced with a new housing and the alignment access slot positioned on the medial side. Refer to MDA SN 1999(09) or Endolite Technical Bulletin No.10. Not to be used with Bilateral amputees of all weights. If fitted to such amputees it should be replaced. Refer to MDA SN 2000(16) or Endolite Technical Bulletin No.12.	MDA	27/04/1999
379242	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
379243	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
379244	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
3c85	FDA product recall PRODUCT Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees, Recall # Z-0363-2007 CODE<.br> Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003. Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063. RECALLING FIRM/MANUFACTURER Recalling Firm: Bock, Otto, Orthopedic Ind., Inc., Minneapolis MN, by letter dated August 11, 2006. Manufacturer: Otto Bock Austria, Wien, Austria. Firm initiated recall is ongoing. REASON A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer. VOLUME OF PRODUCT IN COMMERCE 176 systems DISTRIBUTION Nationwide http://www.fda.gov/bbs/topics/enforce/2007/ENF00989.html	RehabTech	02/12/2007
3c95	FDA product recall PRODUCT Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees, Recall # Z-0363-2007 CODE<.br> Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003. Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063. RECALLING FIRM/MANUFACTURER Recalling Firm: Bock, Otto, Orthopedic Ind., Inc., Minneapolis MN, by letter dated August 11, 2006. Manufacturer: Otto Bock Austria, Wien, Austria. Firm initiated recall is ongoing. REASON A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer. VOLUME OF PRODUCT IN COMMERCE 176 systems DISTRIBUTION Nationwide	RehabTech	02/12/2007
3R36	PRODUCT Otto Bock Modular Knee Joints, Model 3R36, used for lower limb amputees up to 220 pounds body weight, and with moderate activity levels. Recall #Z-990-0. CODE Batch 0150. MANUFACTURER Otto Bock Orthopedische Industrie, Duderstadt, Germany. RECALLED BY Otto Bock Orthopedic Industry, Inc., Minneapolis, Minnesota, by letter dated July 26, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Germany. QUANTITY 51 units were distributed. REASON The prosthetic knee joint could fail due to setscrews, which can come loose.	" FDA"	15/01/2002
3R70	No flexion bumper is provided to stop the 4 bar mechanism hitting itself during maximum flexion. As a result maximum flexion will cause damage to the knee.	Michael Nichols	20/01/2000
3R90	The recall on the 3R90/92 was only issued in America on the early units sold. We only had 5 of the older units sold in Australia, and each was handled individually. The unit has had the issue repaired and no longer has a problem.	Otto Bock A/Asia	22/02/2005
3R90	FDA recalls in the US, details as per print from FDA. PRODUCT - Otto Bock 3R90 and 3R92 Modular Knee Joint with Friction Brake. Recall # Z-1379-04. CODE - No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004. RECALLING FIRM/MANUFACTURER - Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by telephone on July 15, 2004. Firm initiated recall is ongoing. REASON - Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the breaking performance of the knee to malfunction. VOLUME OF PRODUCT IN COMMERCE - 437 devices. DISTRIBUTION - Nationwide.	FDA	15/02/2005
3R92	FDA recalls in the US, details as per print from FDA. PRODUCT - Otto Bock 3R90 and 3R92 Modular Knee Joint with Friction Brake. Recall # Z-1379-04. CODE - No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004. RECALLING FIRM/MANUFACTURER - Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by telephone on July 15, 2004. Firm initiated recall is ongoing. REASON - Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the breaking performance of the knee to malfunction. VOLUME OF PRODUCT IN COMMERCE - 437 devices. DISTRIBUTION - Nationwide.	FDA	15/02/2005
3R92	The recall on the 3R90/92 was only issued in America on the early units sold. We only had 5 of the older units sold in Australia, and each was handled individually. The unit has had the issue repaired and no longer has a problem.	Otto Bock A/Asia	22/02/2005
409120	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409121	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409122	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409123	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409125	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409126	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
409127	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
4R21	When used for hip disarticulation, it is adviced that the clamp tube adaptor be oriented in the medial-latitude plane to reduce the bending moment loading in a high stress concentrated region (the slit) and the clamp mechanism.		27/09/2004
509171	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509172	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re-lubricate the mating surfaces.	David Lee Gow	22/09/2000
509173	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509174	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509175	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509176	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509177	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509178	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509179	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509180	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509181	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509182	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509183	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509184	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509185	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509186	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509187	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
509188	After extended periods in one position, the stiffness adjuster prop may develop a creaking noise. This can be eliminated by adjusting the prop from one extreme to the other and then returning to the preferred position. Exceptionally a spot of petroleum jelly may be required to re lubricate the mating surfaces.	David Lee Gow	22/09/2000
6Y70=235	After using the 6y70=235 for the past 18 months the liner seems to be quite durable with the minor exception of tending to tear the silicon very slightly after prolonged use (< 12/15 months) from the stress of rolling the liner on and off the limb. Rated 9/10 overall. Minor tears started earlier along the opening edge which was not a real problem as I recut the liner slightly shorter the single tear about 75mm from the base of the liner around 7mm long under perspiring conditions would cause the liner to lose its suction and create an air pocket at the base of the liner rendering it useless.	Roger Ricardo	24/03/2003
6Y70=235	after using the 6y70=235 for the past 18 months the liner seems to be quite durable with the minor exception of tending tear to the silicon very slightly after prolonged use < 12/15 months from the stress of rolling the liner on and off the limb 9/10 overall	Ricardo Roger	19/03/2003
D-040400	We have been working a lot with this device, more than 90 cases. In general it is a positive experience, as long as you stick to the rules. It can also be used for stump shrinking. We also have been using it to take special plaster molds.	Thomas de Windt C.P.O. Http://www.sofk.com	30/10/2000
ELP00xxy	FDA Recall - January 25, 2006-06-04 (Enforcement Report) PRODUCT Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR, Recall # Z-0388-06 CODE Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032 RECALLING FIRM/MANUFACTURER Recalling Firm: Ossur, Reykjavik, Ireland, by telephone and letters on October 21, 2005. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing. REASON After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot. VOLUME OF PRODUCT IN COMMERCE 48 units DISTRIBUTION Nationwide	RehabTech	14/09/2006
FRM01804LU	FDA RECALL, 2003 http://www.fda.gov/bbs/topics/enforce/2003/ENF00797.html PRODUCT Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Recall # Z-0815-03. CODE All frames manufactured since the product was released are suspect. RECALLING FIRM/MANUFACTURER Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March 17, 2003. Firm initiated recall is ongoing. REASON Knee frame defect led to breakage and injury. Knee bolt end came loose. VOLUME OF PRODUCT IN COMMERCE 261. DISTRIBUTION Nationwide.	RehabTech	21/09/2004
FRM01804U	FDA RECALL http://www.fda.gov/bbs/topics/enforce/2003/ENF00797.html PRODUCT Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Recall # Z-0815-03. CODE All frames manufactured since the product was released are suspect. RECALLING FIRM/MANUFACTURER Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March 17, 2003. Firm initiated recall is ongoing. REASON Knee frame defect led to breakage and injury. Knee bolt end came loose. VOLUME OF PRODUCT IN COMMERCE 261. DISTRIBUTION Nationwide.	RehabTech	21/09/2004
FRM01851LU	FDA RECALL, 2003 http://www.fda.gov/bbs/topics/enforce/2003/ENF00797.html PRODUCT Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Recall # Z-0815-03. CODE All frames manufactured since the product was released are suspect. RECALLING FIRM/MANUFACTURER Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March 17, 2003. Firm initiated recall is ongoing. REASON Knee frame defect led to breakage and injury. Knee bolt end came loose. VOLUME OF PRODUCT IN COMMERCE 261. DISTRIBUTION Nationwide.	RehabTech	21/09/2004
FRM61750	FDA RECALL, 2003 http://www.fda.gov/bbs/topics/enforce/2003/ENF00797.html PRODUCT Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Recall # Z-0815-03. CODE All frames manufactured since the product was released are suspect. RECALLING FIRM/MANUFACTURER Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March 17, 2003. Firm initiated recall is ongoing. REASON Knee frame defect led to breakage and injury. Knee bolt end came loose. VOLUME OF PRODUCT IN COMMERCE 261. DISTRIBUTION Nationwide.	RehabTech	21/09/2004
K01	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K042	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K043	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K044	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K051	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K06	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K07	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K07J	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K08	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K09	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K0942	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K0951	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
K10	If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section. If used in a modular prosthesis a sheet of 5 mm plastic should be placed between the foot and the foot adapter. The plastic should cover the entire top joining surface of the foot. This will increase the life of the foot especially from delamination between the keel and foam in the heel section.	Jodie Van Rooyen	22/09/2000
KK800	The corner between the posterior linkage bar and the spring lever is a stress concentration and can be the initiation area of a crack leading to fatigue failure. This area needs to be checked during routine inspections.	RehabTech	23/07/2004
L-721000	FDA RECALL, 2003 http://www.fda.gov/bbs/topics/enforce/2002/ENF00741.html PRODUCT Icelock ratchet UX 721, Model L-721000. Recall # Z-0913-2. Designed for use with ICEROSS silicone upper extremity liners for upper extremity amputees. CODE Lots 001,012,021. RECALLING FIRM/MANUFACTURER Recalling Firm: OSSUR North America, Aliso Viejo, CA, by letters on February 27, 2002. Manufacturer: Ossur hf., Iceland. Firm initiated recall is ongoing. REASON Pin does not stay engaged in lock mechanism. VOLUME OF PRODUCT IN COMMERCE 136. DISTRIBUTION Nationwide.	RehabTech	21/09/2004
Model 2000	Isolated incidences of displaced pivot pins. The supplier should be able to provide a quality notice covering the issue.	MDA	27/11/1999
Model 2065	Adapters supplied to the UK after Jan 1999 from batch numbers AT 0199-2 and AT 0799-8 should be replaced. See MDA SN 2000(15)	MDA	02/01/2001
P24800	Potential failure of either proximal plate or hydraulic unit if knee gets reaches in maximum flexion.	Ross Stewart	08/10/2000
P739017	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739018	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739019	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739020	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739021	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739022	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739023	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
P739024	Wear on mating surfaces need to be regularly checked. The wearing of these surfaces can cause shearing of the joining bolt.	RehabTech	18/10/2002
PRO-02C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-02L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-03C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-03L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-04C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-04L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-05C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-05L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-06C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-06L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-07C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-07L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-08C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-08L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-09C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-09L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-10C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-10L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-11C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-11L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-12C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-12L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-13C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-13L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-14C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-14L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-15C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-15L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-16C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-16L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-17C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-17L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-18C	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
PRO-18L	The new TEC Liner skin if used with a shuttle lock, the gel may tend to buckle ( ripple). If no shuttle lock is used the new or old style is OK. The TEC liners old version with the slick skin does not seem to have this problem. The old version can be ordered at the same price from TEC.	David Lee Gow	10/11/2000
RFL0_ _ _0	PRODUCT Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007, Recall # Z-0468-2007 CODE Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. RECALLING FIRM/MANUFACTURER Recalling Firm: Ossur, Reykjavik, Iceland, by letter on November 9th, 2006. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing. REASON Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot. VOLUME OF PRODUCT IN COMMERCE 138 units DISTRIBUTION Nationwide and Internationally http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html		02/12/2007
RFL0_ _ _1	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFL0_ _ _1	PRODUCT Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007, Recall # Z-0468-2007 CODE Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. RECALLING FIRM/MANUFACTURER Recalling Firm: Ossur, Reykjavik, Iceland, by letter on November 9th, 2006. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing. REASON Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot. VOLUME OF PRODUCT IN COMMERCE 138 units DISTRIBUTION Nationwide and Internationally http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html		02/12/2007
RFL00001	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFL00008	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFX0 _ _ _ _	PRODUCT Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007, Recall # Z-0468-2007 CODE Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. RECALLING FIRM/MANUFACTURER Recalling Firm: Ossur, Reykjavik, Iceland, by letter on November 9th, 2006. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing. REASON Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot. VOLUME OF PRODUCT IN COMMERCE 138 units DISTRIBUTION Nationwide and Internationally http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html		02/12/2007
RFX0_ _ _1	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFX0_ _ _2	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFX00001	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFX00002	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
RFX00012	FDA Product Recall posted on Enforcement Report July 21, 2004 04-29 http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html PRODUCT VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04. CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012. RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing. REASON Flawed shock module might cause breakage causing patient to fall. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION Nationwide.	RehabTech	27/07/2004
SAS210	If used with a female tube clamp adapter, the pylon has the potential to interfere with pyramid during alignment. Check adapter and adjacent pyramid for snug and correct connection.	Ross Stewart	08/10/2000
SS-512	Australian Supplier Recalls. The Australian supplier,REIS, have issued recalls on a number of SS-512 pylon adaptors with batch number 2504. It appears that the stainless steel adaptor will loosen from the pylon and either rotate slightly or cause a clicking sound due to the movement. These have been identified and removed in a number of cases and there hasd been no hazard to the patient. It is not known at this stage if leaving them in use (once movement is occurring will ultimately lead to deterioration, however this has been assumed so it is advisable to remove them.) At this stage the supplier has identified the problem as being limited to the 2004 manufactured batch (which can be identified as having an "04" label on the stainless steel adaptor.) Unfortunately , in use, it appears that the label is easily erased and so checks of records should be made to ascertain if it is likely to be an "04" pylon. It is advisable to identify and remove these pylons and return them to the supplier who has been very proactive in this process and response. Affected units (batch number 2504) are replaced by units with batch number 1305. If you have an affected unit or have any further query please contact REIS.	RehabTech	22/06/2005
SS-512	Letter from TiMed indicated that problem has been resolved	RehabTech	22/01/2006
SSK604	The corner between the posterior linkage bar and the spring lever is a stress concentration and can be the initiation area of a crack leading to fatigue failure. This area needs to be checked during routine inspections.	RehabTech	23/07/2004
TWB-4	Product: Externally Assembled Lower Limb Prostheses, AKA, Above knee prostheses appliance/artificial leg. This is a custom device that is labeled: Harry J. Lawall & Son, Philadelphia, Pennsylvania. Recall #Z-295-2. Code: Lot numbers are not used for this custom device. Manufacturer: Teh Lin, Taiwan. Recalled by: Harry J. Lawall & Sons, Inc., Philadelphia, Pennsylvania, by letters of December 30, 1991. Firm-initiated recall ongoing. Distribution: Pennsylvania, New Jersey, Delaware. Quantity: Firm estimates 10 to 25 units are in use. Reason: The Teh Lin above the knee wood block, TWB-4 series component appeared to be fracturing while in use and may cause a severe malalignment of the leg components.	" FDA"	15/01/2002
TWB-4	CORRECTION: Recall #Z-295-2, which appeared in the February 12, 1992 Enforcement Report should read: Product: Externally Assembled Lower Limb Prosthesis, AKA, Above Knee Prosthesis Appliance/Artificial Leg. Only those units manufactured using the Teh Lin above the knee wood block, TWB-4 series are involved. Only units manufactured from 1/91 through 10/91 may contain this component. This is a custom device that is labeled: Harry J. Lawall & Son, Philadelphia, Pennsylvania. Recall #Z-295-2. Reason: The Teh Lin above the knee wood block, TWB-4 series component appeared to be fracturing while in use and may cause a severe malalignment of the leg components.	" FDA"	15/01/2002
TWB-4	PRODUCT Above Knee Prosthetic Wood Block, "TWB-4", used as a component of an artificial leg. Recall #Z-1259-2. CODE Not coded. MANUFACTURER Teh Lin, Taiwan. RECALLED BY Daw Industries, Inc., San Diego, California, by telephone December 31, 1991, and by letter January 23, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada. QUANTITY 166 units were distributed. REASON The TWB-4 component was showing movement which could lead to failure of the finished device.	" FDA"	15/01/2002
TWB-4	Product: Externally Assembled Lower Limb Prostheses, AKA, Above knee prostheses appliance/artificial leg. This is a custom device that is labeled: Harry J. Lawall & Son, Philadelphia, Pennsylvania. Recall #Z-295-2. Code: Lot numbers are not used for this custom device. Manufacturer: Teh Lin, Taiwan. Recalled by: Harry J. Lawall & Sons, Inc., Philadelphia, Pennsylvania, by letters of December 30, 1991. Firm-initiated recall ongoing. Distribution: Pennsylvania, New Jersey, Delaware. Quantity: Firm estimates 10 to 25 units are in use. Reason: The Teh Lin above the knee wood block, TWB-4 series component appeared to be fracturing while in use and may cause a severe malalignment of the leg components.	" FDA"	15/01/2002
TWB-4	CORRECTION: Recall #Z-295-2, which appeared in the February 12, 1992 Enforcement Report should read: Product: Externally Assembled Lower Limb Prosthesis, AKA, Above Knee Prosthesis Appliance/Artificial Leg. Only those units manufactured using the Teh Lin above the knee wood block, TWB-4 series are involved. Only units manufactured from 1/91 through 10/91 may contain this component. This is a custom device that is labeled: Harry J. Lawall & Son, Philadelphia, Pennsylvania. Recall #Z-295-2. Reason: The Teh Lin above the knee wood block, TWB-4 series component appeared to be fracturing while in use and may cause a severe malalignment of the leg components.	" FDA"	15/01/2002
UDAV	The supplier of this component is conducting an ongoing survey of the use if this valve and has indicated that they may provide the valve to interested prosthetists f.o.c. Please contact the supplier directly regarding this.	Manager REHAB Tech 01/02	04/03/2002