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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 Device Recall Offset Adaptor Trial see related information
Date Initiated by Firm April 16, 2009
Date Posted July 23, 2009
Recall Status1 Terminated 3 on April 05, 2010
Recall Number Z-1608-2009
Recall Event ID 52072
510(K)Number K070095  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Offset Adaptor Trial - 4MM, 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-040; All Lot Numbers.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 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		 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 total units, all sizes
Distribution Worldwide 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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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