Recall Z-0420-2008 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652.
| Date | Dec 6, 2007 (initiated Sep 27, 2007) |
| Status | Terminated |
| Reason | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| Root cause | Packaging process control |
| Action | Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians. |
| Quantity | 12 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED Johnson & Johnson Professionals, Inc., May 15, 1995 |