FDA: STAR Ankle Device Has Higher-Than-Expected Risk Of Component Fracture

Mealey's (March 31, 2021, 8:38 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on March 15 issued a safety communication advising doctors and patients of a higher-than-expected risk of fracture of the polyethylene component of the Scandinavian Total Ankle Replacement (STAR) device.  The agency said the fractured component may lead to surgery to repair or replace the device....

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