||April 12, 2013
||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.
||Catalog No: TR7100-L and TR7100-R
Lot Code: All
|Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
|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.
||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
||USA Nationwide Distribution