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U.S. Department of Health and Human Services

Class 2 Device Recall OMNIFIT HA HIP STEM

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  Class 2 Device Recall OMNIFIT HA HIP STEM see related information
Date Initiated by Firm November 13, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0891-2009
Recall Event ID 50485
510(K)Number K982032  
Product Classification prosthesis, hip, - Product Code MEH
Product Omnifit HA Hip Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Code Information x6017-0525A OMNIFIT HA HIP STEM #5 3PMMNE and 6017-1035A OMNIFIT HA HIP STEM #10 NKAMME 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
FDA Determined
Cause 2		 Packaging
Action Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
Quantity in Commerce 322 total units - all types
Distribution Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
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 = MEH and Original Applicant = OSTEONICS CORP.
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