Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-00
FDA device recall Z-0531-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
- Action taken
- Consignees were notified via letter dated 11/10/05 and asked to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDB
- Distribution
- Nationwide, Argentina, Ireland, New Zealand and Spain.
- Date initiated
- 2005-11-08
- Date posted
- 2006-02-16
- Date terminated
- 2006-06-16
- 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 TOTAL ELBOW SYSTEM (K992656) | DePuy Orthopaedics, Inc. | 1999-11-05 |