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In another shot to beleaguered J&J, the FDA has hit it's DEPUY unit with selling hip systems without approval.The FDA said in the letter that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.
The agency ordered DePuy to immediately stop selling the Corail products or face further enforcement action. Failure to comply could result in product seizure, injunction or civil penalties.
Depuy has 15 days to comply with the order.
If you believe that you have received a defective Depuy Hip System, contact attorney Chris Hellums at Chrish@pittmandutton.com or call toll free 1-866-515-8880 for a free case evaluation.