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Stryker's OtisMed Pleads Guilty For Selling FDA-Rejected Cutting Guides

This article was originally published in The Gray Sheet

Executive Summary

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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