Recall Z-1069-03 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
Foundation Knee System, non-porous Femur Size 8, Right
| Date | Jul 30, 2003 (initiated Apr 24, 2003) |
| Status | Terminated |
| Reason | Product container was labeled incorrectly indicating left femur instead of right. |
| Root cause | Other |
| Action | The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors. |
| Quantity | 14 unimplanted units |
| Distribution | PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923277 | FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc., Feb 9, 1993 |