Recall Z-1382-04 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
| Date | Aug 24, 2004 (initiated Jan 15, 2004) |
| Status | Terminated |
| Reason | Screw size included in system was incorrect |
| Root cause | Other |
| Action | DePuy notified the sales territories via verbal contact with the distributors on 1/15/04. |
| Quantity | 1 unit |
| Distribution | IA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS Johnson & Johnson International, Nov 9, 1992 |