FDA Issues Top Recall For Stryker Cranial Implants

Law360, New York (December 29, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration has issued a Class I recall notice for Stryker Corp.’s custom cranial implant kits, previously taken off the market in October, after determining that the reconstructive implants pose an “imminent hazard to health,” according to the company.

On Tuesday, Stryker announced that the FDA has classified the recall as Class I — reserved for product defects most likely to cause injury or death — on the basis that the implants may not have been properly sterilized and could cause infections,...
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