FDAFDA · Food and drugs·Recall number Z-1052-2013
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.
Published April 24, 2013 · Recall initiated: November 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- USA Nationwide Distribution
- Lot
- Catalog No: TR7100-L and TR7100-R Lot Code: All
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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