FDA SEEKS INJUNCTION AGAINST ORTHOPEDIC DEVICEMAKER

The FDA is seeking a permanent injunction against Endotec and three of its executives to stop their illegal distribution of unapproved total-joint replacement devices, the agency announced Oct. 6.

The government's complaint charges Endotec with violating the Federal Food, Drug and Cosmetic Act by distributing total-joint replacement devices without an approved premarket application or an approved clinical study, the FDA said. The complaint was filed by the Department of Justice in the U.S. District Court for the Middle District of Florida.

The firm has been distributing the devices since March 15, 2002, despite FDA warnings that those actions were illegal, according to the complaint.

The FDA notice can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01483.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01483.html).