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U.S. Department of Health and Human Services

Class 1 Device Recall ShapeMatch Cutting Guides

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 Class 1 Recall
ShapeMatch Cutting Guides
see related information
Date Posted April 12, 2013
Recall Status1 Open
Recall Number Z-1052-2013
Recall Event ID 64308
Premarket Notification
510(K) Numbers
K110533  K122053 
Product Classification Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer - Product Code MBH
Product ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
Code Information Catalog No: TR7100-L and TR7100-R Lot Code: All
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Manufacturer Reason
for Recall
With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.
Quantity in Commerce 7868 units
Distribution USA Nationwide 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 = MBH and Original Applicant = STRYKER CORP.
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