Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Co
FDA device recall Z-0420-2008 · posted 2007-12-06 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NJL
- Quantity affected
- 12
- Distribution
- Nationwide.
- Date initiated
- 2007-09-27
- Date posted
- 2007-12-06
- Date terminated
- 2008-04-30
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED (K950010) | Johnson & Johnson Professionals, Inc. | 1995-05-15 |