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U.S. Department of Health and Human Services

Class 2 Device Recall Acclaim

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  Class 2 Device Recall Acclaim see related information
Date Initiated by Firm November 08, 2005
Date Posted February 16, 2006
Recall Status1 Terminated 3 on June 16, 2006
Recall Number Z-0530-06
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, sterile; catalog # 1722-60-000.
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 2		 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.
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