Stryker Corporation (SYK) Recall for ShapeMatch Guides Listed as Class I by FDA
4/12/2013 8:21:22 AM
Stryker Corporation (NYSE: SYK) announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. In November 2012, Stryker Orthopaedics instructed all U.S. registered ShapeMatch surgeons to discontinue use and ordering of ShapeMatch Cutting Guides and in January 2013 voluntarily recalled the product.
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