Recall Z-1566-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
| Date | Sep 21, 2005 (initiated Jul 28, 2005) |
| Status | Terminated |
| Reason | Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit. |
| Root cause | Other |
| Action | Recall was initiated by letter to sales agents on 07/28/2005. |
| Quantity | 93 primary units and 56 revision units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041066 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P., Mar 24, 2005 |