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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JDB
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