Class 2 Device Recall Acclaim

• Date Initiated by Firm: November 08, 2005
• Date Posted: February 16, 2006
• Recall Status: Terminated on June 16, 2006
• Recall Number: Z-0531-06
• Recall Event ID: 34018
• 510(K)Number: K992656
• Product Classification: Prosthesis, Elbow, Semi-Constrained, Cemented - Product Code JDB
• Product: Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-372-7179
• Manufacturer Reason for Recall: The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JDB and Original Applicant = DEPUY ORTHOPAEDICS, INC.