Z-0531-06

Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog #...

Name: Z-0531-06 Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog #...
Creator: Depuy Orthopaedics, Inc.
Published: 2005-11-08
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2005-11-08 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000 on 2005-11-08. The reason FDA records is "The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0531-06
Status: Terminated
Initiated: 2005-11-08
Posted: 2006-02-16
Terminated: 2006-06-16
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.
Product code: JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Reason for recall: The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
FDA 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.
Product codes and lots: All units.

Product code JDB

K992656Class IIDepuy Total Elbow SystemDePuy Orthopaedics, Inc. / cleared 1999-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)