FDA classifies voluntary ShapeMatch Cutting Guides recall as Class I recall

The FDA has issued a Class I recall for Stryker’s ShapeMatch Cutting Guides used for total knee arthroplasty following Stryker’s voluntary recall of these products in January 2013.

“As stated in the January 2013 Product Notification, Stryker recommended that patient follow-up beyond the routine standard of care was not necessary. The ShapeMatch Cutting Guides have not been available on the market since November 2012,” a representative from Stryker Orthopaedics told Orthopedics Today. “This voluntary recall does not affect the Triathlon Knee System or the Triathlon standard instrumentation.”

There have been 41 malfunctions and 3 temporary medically reversible injuries reported to the FDA related to the guides, according to the FDA recall. Stryker Orthopaedics sent a voluntary recall notice to surgeons and hospital risk managers after receiving postmarket product complaints over a discrepancy between the planning ranges specified in the 510(k) clearance and the final product, which could cause the knee to not function properly.

Stryker is advising patients who underwent total knee arthroplasty where the ShapeMatch guide was used should contact their surgeon. For patients with questions about the Class I recall, Stryker advises calling 1-888-STRYKER from 8 am – 8 pm EDT Monday through Friday.

Reference:

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