FDA-Device2013-04-24Class I
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.
Stryker Howmedica Osteonics Corp.
Hazard
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.
Sold states
USA Nationwide Distribution
Affected count
7868 units
Manufactured in
325 Corporate Drive, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2013Don't want to check this manually?
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