Recall Z-0057-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Depuy Orthopaedics, Inc.
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
| Date | Oct 21, 2006 (initiated Sep 14, 2006) |
| Status | Terminated |
| Reason | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. |
| Root cause | Other |
| Action | The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product. |
| Quantity | 9 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc., Jul 10, 1996 |