Stryker Corporation has recalled its ShapeMatch Cutting Guides due to manufacturing concerns with the device. The ShapeMatch is intended to be used as a patient specific surgical instrumentation to assist in the positioning of total knee replacement components and is used to guide the marking of bone before cutting.
Stryker has acknowledged that the guides may have been manufactured outside of the planning ranges specified in a 2011 clearance issued by the Food and Drug Administration (FDA). The FDA has reviewed the recall and decided to issue a “Class I” label, reserved for only the products with the most serious safety concerns.
Patients who have had knee replacement surgery where the ShapeMatch guide was used, are asked to contact their surgeon, contact Stryker at 1-888-STRYKER or submit a report directly to the FDA via its online MedWatch system.