Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.
FDA Recall Z-0530-06 · Posted 2006-02-16
Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJDB
Date Initiated2005-11-08
Date Terminated2006-06-16
Reason for Recall
The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
Firm Action
Consignees were notified via letter dated 11/10/05 and asked to return product.
Root Cause
Other
Distribution Pattern
Nationwide, Argentina, Ireland, New Zealand and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.