Date Initiated by Firm | June 18, 2009 |
Date Posted | August 18, 2009 |
Recall Status1 |
Terminated 3 on August 27, 2012 |
Recall Number | Z-1822-2009 |
Recall Event ID |
52525 |
510(K)Number | K022077 K993601 |
Product Classification |
Hip Semi-Constrained Metal/Polymer Uncemented Prosthesis - Product Code LWJ
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Product | V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp.,
Stryker Ireland, Carrigtwohill County Cork, Ireland;
Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. |
Code Information |
lot # 29213701;Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
|
For Additional Information Contact | Colleen O'Meara 201-831-5950 |
Manufacturer Reason for Recall | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. |
FDA Determined Cause 2 | Process control |
Action | Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions. |
Quantity in Commerce | 13 total, both products. |
Distribution | Nationwide Distribution |
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 = LWJ
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