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Terminated

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.

FDA Recall Z-1052-2013 · Posted 2013-04-12

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2012-11-08
Date Terminated2021-01-11
Product Quantity7868 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122053SHAPEMATCH CUTTING GUIDEStryker Corp. · 2012-10-24K110533STRYKER PATIENT SPECIFIC CUTTING GUIDEStryker Corp. · 2011-05-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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