Surgery tool sold without FDA OK leads to jail sentence

The former chief executive of a medical device company that admitted to distributing knee replacement surgery tools using a marketing plan rejected by the Food and Drug Administration will go to jail.

Charli Chi, of San Francisco, pleaded guilty along with the company, OtisMed Corp., in December. The 46-year-old was sentenced Friday to 24 months in prison.

The company was fined more than $80 million for the criminal and civil charges for distributing the knee replacement surgery cutting guides.

The company sold orthopedic cutting guides used by surgeons during knee replacement surgery using claims that weren’t evaluated by the FDA and were later rejected.

OtisMed was acquired by Michigan’s Stryker Corp. in November 2009. Prosecutors say Stryker was not aware the devices were sold without FDA approval and cooperated with the government’s investigation.