August 25, 2010NEW BRUNSWICK, N.J. (AP) -- A Johnson & Johnson business that makes joint replacements has been warned by the Food and Drug Administration that it's breaking the law with its marketing of two products.
The FDA says Johnson & Johnson's DePuy Orthopaedics is selling one product that was never approved for sale and is selling another product for uses that have not been specifically approved.
In a letter to the company, the FDA says the company is marketing its Corail Hip System for two unapproved uses.
The agency says it never approved the TruMatch Personalized Solution System, software that creates a detailed view of a patient's knee.
The FDA has told the company to stop selling the hip system for unapproved uses and to provide information needed to review the software system.
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