The OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them. When the company did apply for F.D.A. review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective.
In December, OtisMed and its former chief executive pleaded guilty in Federal District Court in Newark to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 of its OtisKnee devices from 2006 to 2009 without F.D.A. approval.
If you or a loved one have been injured by an Otis knee implant please contact Jamie Sheller Esq. at 1800 883 2299
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