Reported Apr 24, 2013 · Terminated
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific…
Stryker Howmedica Osteonics Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- ShapeMatch Cutting Guides Product UsageThe 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
- Lot codes and dates
- Catalog NoTR7100-L
- and TR7100-R Lot CodeAll
- Amount recalled
- 7868 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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