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Recall Observatory FDA recall evidence

Device 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.

Z-1052-2013

November 08, 2012

Class I

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 64308
Status
Terminated
Classification
Class I
Quantity
7868 units
Official record key
device-enforcement:Z-1052-2013

Official wording

Reason: 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.

Code information: Catalog No: TR7100-L and TR7100-R Lot Code: All

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.