FDA warns J&J re: Joint-replacement marketing

The U.S. Food and Drug Administration has sent Johnson & Johnson a letter warning that it has been improperly marketing two of its products, TruMatch Personalized Solutions Systems and the Corail hip System. The FDA has ordered the company to stop marketing the products for certain uses until they are awarded approvals.The letter stated “Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice,” the agency said in the letter. “These actions include, but are not limited to seizure, injunction, and or civil money penalties.” The FDA letter also said that the company is selling a product never approved for sale. This product, the TruMatch Personalized Solution System uses CT scanning technology providing a 3-D view of the knee for the surgeons to position the implant.