Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals.

According to the FDA and Justice Department, the companies will pay $79,560,400 plus interest to cover criminal forfeiture and a separate civil settlement that resolved whistleblower claims. OtisMed also agreed not to participate in federal healthcare programs for 20 years.

Former OtisMed CEO Charlie Chi pleaded guilty to three counts of introducing adulterated medical devices into interstate commerce. He faces up to one year in prison and a fine of up to $100,000 for each count.

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