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Terminated

Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.

FDA Recall Z-0531-06 · 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.

K992656DEPUY TOTAL ELBOW SYSTEMDePuy Orthopaedics, Inc. · 1999-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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