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FDA warns J&J’s DePuy Orthopaedics unit on product marketing violations

Posted by Frank Spector | Aug 25, 2010 | 0 Comments

The AP reports that the Food and Drug Administration has warned Johnson & Johnson's DePuy Orthopaedics, Inc. unit that “it is illegally marketing two products,” one which “was never approved for sale, and is selling another product for uses that have not been specifically approved.” In its Aug. 19 “letter to the company, the FDA wrote that DePuy is marketing its Corail Hip System for two unapproved uses, and promoting those uses in an online brochure.”

Modern Healthcare reported that the agency's letter “asserts that DePuy has been selling its TruMatch Personalized Solutions System — a scanning device that helps surgeons determine knee implant placement prior to surgery — without submission of a premarket approval application.” The FDA is now “requiring DePuy to submit a premarket approval application for an official review and decision on whether the device can be legally marketed.” Meanwhile, the agency has “told DePuy to cease off-label marketing of its Corail Hip System.”

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Frank Spector

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