DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, D
FDA device recall Z-1686-2009 · posted 2009-08-21 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.
- Action taken
- The firm's sales staff was notified by email on May 7, 2009, and the recall was expanded to include additional lots on May 29, 2009, instructing them to remove the affected lots from their inventory and the inventory of any consignees, to provide the consignees with a copy of the recall letter, and to return the product to the firm. Hospital consignees were notified by letter dated May 7, 2009, as well as by updated letter on May 29, 2009. A dear doctor letter dated May 29, 2009 was issued to implanting surgeons advising them of the issue. Direct questions to Depuy Customer Service by calling 1-800-366-8143.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 260
- Distribution
- Nationwide.
- Date initiated
- 2009-05-07
- Date posted
- 2009-08-21
- Date terminated
- 2010-10-25
- 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 (K943462) | Johnson & Johnson Professionals, Inc. | 1994-12-21 |