Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 2, 9.5 mm; Ref 1498-12-208.
FDA device recall Z-1148-05 · 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
- NJL
- Quantity affected
- 24
- 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 PRESERVATION UNICONDYLAR KNEE PROSTHESIS (K010810) | DePuy Orthopaedics, Inc. | 2001-04-18 |