FDA-Rejected Knee Replacement Device Used in Thousands of Surgeries
Feds: More than 18,000 OtisKnee cutting guides were sold without FDA approval. OtisMed Corp. and its former CEO admitted to distributing knee replacement surgery cutting guides after the FDA had rejected their application for marketing clearance, the U.S. Department of Justice announced. OtisMed — now a subsidiary of Stryker — and its CEO Charlie Chi
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