Recall Z-1369-04 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
| Date | Aug 24, 2004 (initiated Dec 22, 2003) |
| Status | Terminated |
| Reason | The collar was incorrectly etched for the R (right) and L (Left) orientation |
| Root cause | Other |
| Action | Depuy notified distributors at the various territories via verbal contact on 12/23/2003 |
| Quantity | 1 unit |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952830 | DARWIN KNEE SYSTEM (TC3) Johnson & Johnson Professionals, Inc., Jan 18, 1996 |