U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Prosthesis Knee - Product Code JWH
원인
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.
조치
Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
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.
제품 설명
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-