Recall Z-1623-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Endotec, Inc.
Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral
| 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 | 51 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
| K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT Endotec, Inc., Feb 12, 1997 |