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Terminated

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-

FDA Recall Z-1621-2010 · Posted 2010-05-20

Recalling FirmEndotec, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-06-05
Date Terminated2013-10-22
Product Quantity3169 Pieces

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.

Firm Action

Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1Endotec, Inc. · 2002-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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