Stryker Recall Gets FDA’s Most Serious Classification

Law360, New York (April 11, 2013, 7:02 PM EDT) -- The U.S. Food and Drug Administration has classified a voluntary recall of a Stryker Corp. medical device used in knee replacement surgeries as a Class I, the most serious type of callback, in which using a product can cause serious health problems, the company said Wednesday.

Stryker recalled its ShapeMatch Cutting Guides in January after instructing surgeons in November to stop ordering or using the product. The guides are used during total knee replacement surgeries, to help place the components of the new knee and guide...
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