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U.S. Department of Health and Human Services

Class 2 Device Recall Endotec, Prosthesis Knee

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 Class 2 Device Recall Endotec, Prosthesis Knee see related information
Date Posted May 20, 2010
Recall Status1 Terminated on October 22, 2013
Recall Number Z-1621-2010
Recall Event ID 52527
510(K)Number K012702 
Product Classification Prosthesis Knee - Product Code JWH
Product Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))

The B-P Knee Replacement System is composed of several components used to provide surgeons with different intra-operative options. All metallic components are available in six sizes and are fabricated from Ti-6Al-4V titanium alloy by Endotec.

BP Knee Replacement System Component, Modular Femoral Component:

Size 5 Left Modular Femoral Component, Catalog: 04-31-2105, Lot No. 04-31-2105A;
Size 4 Left Modular Femoral Component, Lot No. 04-31-2104A,
Size 6 Left Femoral Component, Lot No. 04-31-2106A1.

BP Knee Replacement System Component, Narrow Femoral Component:
Size 3 Right Narrow Femoral Component Lot No. 04-31-1303C,
Size 3 Left Narrow Femoral Component Lot No. 04-31-2303C,
Size 4 Right Narrow Femoral Component Lot No. 04-31-1304C,
Size 4 Left Narrow Femoral Component Lot No. 04-31-2304C.

BP Knee Replacement System Component, All Poly Patella:
Size 1 All Poly Patella Lot No. 04-34-0201B, 04-34-0201C, 04-34-0201D, 04-34-0201E.
Size 2 All Poly Patella Lot No. 04-34-0202B, 04-34-0202C, 04-34-0202D, 04-03-0202E.

BP Knee Replacement System Component, 3 Peg Patella:
Size 4 3-Peg Patella Lot No. 04-34-0004H.

BP Knee Replacement System Component, Conforming Bearing:
1x0mm Conforming Bearing Catalog: 04-33-001,
1x2.5mm Conforming Bearing Catalog: 04-33-0011,
1x5mm Conforming Bearing Catalog: 04-33-0021,
1x7.5mm Conforming Bearing Catalog: 04-33-0031,
2x0mm Conforming Bearing Catalog: 04-33-0002,
2x2.5mm Conforming Bearing Catalog: 04-33-0012,
2x5mm Conforming Bearing Catalog: 04-33-0022,
2x7.5mm Conforming Bearing Catalog: 04-33-0032,
3x0mm Conforming Bearing Catalog: 04-33-0003,
3x2.5mm Conforming Bearing Catalog: 04-33-0013,
3x5mm Conforming Bearing Catalog: 04-33-0023,
3x7.5mm Conforming Bearing Catalog: 04-33-0033,
4x0mm Conforming Bearing Catalog: 04-33-0004,
4x2.5mm Conforming Bearing Catalog: 04-33-0014,
4x5mm Conforming Bearing Catalog: 04-33-0024,
4x7.5mm Conforming Bearing Catalog: 04-33-0034,
5x0mm Conforming Bearing Catalog: 04-33-0005,
5x2.5mm Conforming Bearing Catalog: 04-33-0015
5x5mm Conforming Bearing Catalog: 04-33-0025,
5x7.5mm Conforming Bearing Catalog: 04-33-0035,
6x0mm Conforming Bearing Catalog: 04-33-0006,
6x2.5mm Conforming Bearing Catalog: 04-33-0016,

BP Knee Replacement System Component, Screw Stop:
Size 4-6 Screw Stop Catalog: 03-12-0036.

BP Knee Replacement System Component, Tibial Component Type 1 w/o Biocoat:
Size 1 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0401,
Size 2 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0402,
Size 3 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0403,
Size 4 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0404,
Size 5 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0405,
Size 6 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0406.

BP Knee Replacement System Component, Tibial Component Type 1:
Size 1 Type 1 Tibial Component Catalog: 04-32-0001,
Size 3 Type 1 Tibial Component Catalog: 04-32-0003,
Size 4 Type 1 Tibial Component Catalog: 04-32-0004.

BP Knee Replacement System Component, Tibial Component Type 2:
Size 3 Type 2 Tibial Component Catalog: 04-32-0013.

BP Knee Replacement System Component, Tibial Component Type 0:
Size 5 Type 0 Tibial Platform Catalog: 04-32-0065.

BP Knee Replacement System Component, Femoral Component w/o Biocoat:
Size 1 Right Femoral Component w/o Biocoat Catalog: 04-31-1201,
Size 1 Left Femoral Component w/o Biocoat Catalog:04-31-2201,
Size 2 Right Femoral Component w/o Biocoat Catalog: 04-31-1202,
Size 2 Left Femoral Component w/o Biocoat Catalog:04-31-2202,
Size 3 Right Femoral Component w/o Biocoat Catalog:04-31-1203,
Size 3 Left Femoral Component w/o Biocoat Catalog:04-31-2203,
Size 4 Right Femoral Component w/o Biocoat Catalog:04-31-
Code Information Lot No.
03120036E1NN370
04220001CNN320
04311003JNN325
04311003KNN344
04311004INN390
04311006DNN323
04311201ANN335
04311201BNN347
04311201CNN375
04311201CNN374
04311201DNN384
04311202BNN335
04311202CNN341
04311202D1NN370
04311202D3NN365
04311202DNN365
04311202E1NN384
04311203BNN340
04311203CNN350
04311203DNN368
04311203D1NN360
04311203ENN382
04311203E1NN382
04311204BNN337
04311204CNN338
04311204DNN375
04311205BNN337
04311205CNN341
04311205DNN386
04311205ENN386
04311206ANN341
04311303CNN344
04311304CNN331
04312003JNN324
04312003KNN334
04312005FNN320
04312006DNN328
04312104ANN362
04312105ANN362
04312106A1NN362
04312201ANN335
04312201BNN341
04312201CNN384
04312201DNN375
04312202BNN335
04312202CNN340
04312202DNN365
04312202D1NN375
04312202D2NN366
04312202ENN390
04312202E2NN390
04312202E3NN390
04312202E4NN390
04312203BNN340
04312203CNN350
04312203DNN375
04312203D1NN360
04312203D2NN382
04312203D3NN382
04312203E1NN388
04312204ANN333
04312204BNN335
04312204CNN370
04312205BNN340
04312205CNN347
04312205ENN386
04312206ANN340
04312303CNN334
04312304CNN331
043200013INN319
04320003D1NN386
04320004CNN330
04320065A1NN331
04320065A1NN319
04320303ANN380
04320401CNN344
04320401DNN347
04320401E1NN384
04320402A1NN327
04320402A2NN324
04320402CNN347
04320402DNN338
04320402D1NN331
04320402ENN372
04320402E1NN383
04320402E1NN365
04320402E2NN370
04320402E2NN376
04320402E3NN365
04320402F1NN381
04320402FNN381
04320402F2NN388
04320402F3NN383
04320403CNN344
04320403DNN338
04320403ENN361
04320403E1NN370
04320403E2NN377
04320403E3NN372
04320403FNN386
04320403F2NN388
04320403F3NN383
04320403GNN366
04320403G1NN372
04320404CNN343
04320404DNN337
04320404ENN390
04320404E1NN370
04320405A1NN317
04320405A2NN326
04320405A3NN325
04320405CNN351
04320405DNN366
04320405D1NN372
04320405FNN391
04320406A1NN321
04320406A2NN324
04320406CNN347
04330001DNN321
04330001ENN341
04330001FNN348
04330002FNN333
04330002GNN333
04330002HNN333
04330002INN349
04330002JNN361
04330003GNN336
04330003HNN333
04330003INN337
04330003JNN354
04330003KNN352
04330003LNN385
04330004GNN317
04330004HNN319
04330004INN357
04330004JNN357
04330005GNN336
04330005HNN379
04330005INN361
04330005JNN362
04330005KNN359
04330006HNN339
04330011CNN332
04330011DNN332
04330011ENN341
04330011FNN343
04330012FNN341
04330012GNN332
04330012HNN333
04330012INN353
04330012JNN349
04330012KNN387
04330013GNN355
04330013HNN341
04330013INN345
04330013INN348
04330013JNN345
04330013KNN350
04330014GNN353
04330014HNN327
04330014INN320
04330014KNN353
04330015GNN361
04330015HNN336
04330015JNN352
04330015KNN361
04330016HNN339
04330016INN339
04330021CNN332
04330021DNN337
04330021ENN348
04330021FNN341
04330022FNN366
04330022GNN334
04330022HNN335
04330022INN348
04330022JNN348
04330023GNN355
04330023HNN322
04330023INN332
04330023JNN344
04330023KNN348
04330024GNN338
04330024HNN334
04330024JNN352
04330025GNN336
04330025HNN336
04330025INN337
04330031CNN333
04330031DNN333
04330031ENN347
04330031FNN346
04330032FNN343
04330032GNN341
04330032HNN358
04330032JNN350
04330032INN350
04330032INN350
04330033GNN339
04330033INN332
04330033JNN345
04330033KNN349
04330034HNN338
04330034INN340
04330034KNN350
04330035GNN340
04330035HNN336
04330035KNN359
04340003FNN359
04340004HNN354
04340201BNN328
04340201CNN327
04340201DNN362
04340201ENN359
04340202BNN322
04340202CNN319
04340202DNN358
04340202ENN369
04220001CNN320.
Recalling Firm/
Manufacturer
Endotec, Inc.
2546 Hansrob Rd
Orlando FL 32804-3318
407-822-0021
For Additional Information Contact
407-822-0021
Manufacturer Reason
for Recall
Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
FDA Determined
Cause 2
Other
Action Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in Commerce 3169 Pieces
Distribution Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENDOTEC, INC.
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