News
Knee Replacement Device Unapproved, but Used in Surgery
This article in the New York Times states that 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. Read more here.
Last modified: Wed, 04 Mar 2015 15:08:31 GMT