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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 Recall
OMNIFIT HA HIP STEM
see related information
Date Posted January 26, 2009
Recall Status1 Terminated on January 20, 2010
Recall Number Z-0891-2009
Recall Event ID 50485
Premarket Notification
510(K) Numbers
K020989  K022555  K031744  K041170  K050741  K053514 
K070095  K070963  K932519  K941366  K955731  K982032 
K983226 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - 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, New Jersey 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
PRODUCTION CONTROLS: Packaging Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
510(K)s with Product Code = MEH and Original Applicant = IND DIAGNOSTIC INC.
510(K)s with Product Code = MEH and Original Applicant = OSTEONICS CORP.
510(K)s with Product Code = MEH and Original Applicant = STRYKER ORTHOPAEDICS
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