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HomeRegulatory & QualityOrthopedic Implant Maker Accused of Violating Federal Law

Orthopedic Implant Maker Accused of Violating Federal Law

Article-Orthopedic Implant Maker Accused of Violating Federal Law

The Department of Justice has filed a complaint against Endotec Inc. (Orlando, FL), charging the company with illegally distributing total joint replacement devices. An article reported on devicelink.com states that FDA is seeking a permanent injunction against Endotech, its president, medical director, and director of regulatory affairs. According to the article, the company sold the implants without an approved PMA or approved clinical study.

If true, this violates federal law, because FDA hadn't reviewed valid data demonstrating the safety and effectiveness of the devices. The complaint also says that despite FDA warnings, Endotech has been distributing the devices since March 2002.

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