Recall Z-1625-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Endotec, Inc.
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component:
| 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 | 50 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 |