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U.S. Department of Health and Human Services

Class 2 Device Recall V 40 Femoral Head

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  Class 2 Device Recall V 40 Femoral Head see related information
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 K993601  K022077  
Product Classification Hip Semi-Constrained Metal/Polymer Uncemented Prosthesis - Product Code LWJ
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
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 = LWJ and Original Applicant = HOWMEDICA OSTEONICS CORP.
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