Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are Recalled by Stryker Howmedica Osteonics Corp. Due to With regards to ShapeMatch Cutting Guides using MRI...

Date: November 8, 2012
Company: Stryker Howmedica Osteonics Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Howmedica Osteonics Corp. directly.

Affected Products

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.

Quantity: 7868 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report