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FDA issues a Class I Recall on Shapematch® Cutting Guides

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shapematch recall, stryker recall, knee replacement surgery

Recalled ShapeMatch guides could cause faulty knee surgeries.

After reviewing a voluntary  recall made by Stryker Corporation of its ShapeMatch Cutting Guides, the FDA has decided to issue a Class I Recall for the product.

The cutting guides are designed to be used in knee replacement surgery by helping a surgeon position and guide the marking of a bone before cutting begins. Stryker Orthopaedics ordered the ShapeMatch’s discontinuation of use in operating rooms in November of 2012. Since then, ShapeMatch Cutting Guides have not been available on the market.

The following January, Stryker then voluntarily recalled the cutting guides by issuing a product notification to hospitals describing the harms that could be associated with using the affected products which could later lead to failed knee replacement surgeries. The notification stated that the cutting guides were recalled due to the possibility that the products were not manufactured according to certain outlines, or had been manufactured outside of clearance.

Patients who have had surgery with professionals using ShapeMatch Cutting Guides who feel discomfort in the knee or feel their knee is malfunctioning should contact their surgeon. Stryker Corporation is also ready to receive phone calls in regards to this issue at 1-888-STRYKER. Those without discomfort should know that any surgical follow-ups beyond routine aren’t necessary.

The recall was caused by investigations into product complaints during standard post-market surveillance. This recall does not affect any other Stryker products like Triathlon Knee System or Triathlon standard instrumentation.