Recall Z-1621-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Endotec, Inc.
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 Kn
| Date | May 20, 2010 (initiated Jun 5, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 Endotec, Inc., Jan 30, 2002 |