Ex-OtisMed CEO Gets Two Years for Selling Unapproved Devices

A federal judge in New Jersey recently sentenced former OtisMed CEO Charlie Chi, 46, to two years in prison for intentionally distributing a knee replacement surgery cutting guide even after FDA had declined to clear it.

Chi pleaded guilty in December to three counts of distributing adulterated medical devices in interstate commerce in violation of the federal Food, Drug, and Cosmetic Act. Chi went against the instructions of FDA, legal counsel, and his own board of directors, according to federal prosecutors.

Chi’s actions took place before Stryker acquired California-based OtisMed in 2009. But Stryker still ended up stuck with a criminal fine of $34.4 million, as well as $5.16 million in criminal forfeiture, over the case last year.

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