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U.S. Department of Health and Human Services

Class 2 Device Recall Offset Adaptor Trial

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 Class 2 Recall
Offset Adaptor Trial
see related information
Date Posted July 23, 2009
Recall Status1 Terminated on April 05, 2010
Recall Number Z-1609-2009
Recall Event ID 52072
Premarket Notification
510(K) Number
K070095 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.
Code Information Catalog Number 5570-T-060; All Lot Numbers.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall
Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.
Quantity in Commerce 2498 units, all sizes
Distribution Worldwide Distribution.
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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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