Former OtisMed CEO Sentenced To Two Years For Selling FDA-Rejected Knee Devices
This article was originally published in The Gray Sheet
The sentencing, which also includes an additional one year of supervised release and a $75,000 fine, concludes a long-running investigation into the firm, which is now a subsidiary of Stryker.
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The unit and its former CEO admitted to selling knee-replacement instruments even after FDA rejected a 510(k), prior to OtisMed being acquired by Stryker in 2009. The legal resolution comes with about $80 million in fines and possible jail time for the former CEO. Also, Stryker has agreed to conduct an audit on the FDA approval status of devices in its portfolio.
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