Recall Z-0530-06 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Depuy Orthopaedics, Inc.
Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.
| Date | Feb 16, 2006 (initiated Nov 8, 2005) |
| Status | Terminated |
| Reason | The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 11/10/05 and asked to return product. |
| Distribution | Nationwide, Argentina, Ireland, New Zealand and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992656 | DEPUY TOTAL ELBOW SYSTEM DePuy Orthopaedics, Inc., Nov 5, 1999 |