Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2012-11-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1052-2013
Date of alert
2012-11-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Stryker Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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