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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 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
Premarket Notification
510(K) Number
K012702 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - 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, Florida 32804-3318
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/UNDETERMINED: Pending
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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