Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.
FDA device recall Z-1163-05 · posted 2005-08-12 · 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 18
- Distribution
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
- Date initiated
- 2005-05-26
- Date posted
- 2005-08-12
- Date terminated
- 2005-12-02
- 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 |
|---|---|---|
| DEPUY SIGMA TIBIAL INSERTS (K033272) | DePuy Orthopaedics, Inc. | 2004-02-05 |