Tags: otis | knee | device | replacement | fda

Knee Surgery Device Used on Thousands of Patients Without FDA Approval

By    |   Monday, 09 February 2015 04:52 PM

The maker of the OtisKnee surgical knee-replacement devices started selling them before seeking clearance from the Food and Drug Administration.

In addition, the FDA rejected the OtisMed Corp.’s application once the company did apply for FDA approval for the OtisKnee, The New York Times reports.

In turning down the applicaiton, 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 FDA approval.
 
In announcing an $80 million settlement of criminal and civil charges against OtisMed, United States Attorney Paul J. Fishman said patients “should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved.”
 
About 700,000 knee replacements are performed every year, making it the most common elective surgery in the U.S.
 
Steven B. Haas, chief of knee service at the Hospital for Special Surgery in Manhattan, said OtisMed pioneered the use of disposable surgical instruments, but hadn’t demonstrated that the OtisMed alignment method was effective.

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The maker of the OtisKnee surgical knee devices started selling them before seeking clearance from the Food and Drug Administration.
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Monday, 09 February 2015 04:52 PM
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