DePuy Orthopaedics, a division of Johnson & Johnson, has received a Food and Drug Administration warning letter regarding unapproved marketing of a surgical-assist software system and off-label promotion of a hip-implant product.
The FDA letter, dated Aug. 19 and sent to DePuy President David Floyd, 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 agency is requiring DePuy to submit a premarket approval application for an official review and decision on whether the device can be legally marketed.
FDA officials have also told DePuy to cease off-label marketing of its Corail Hip System. The system is approved for certain kinds of hip-replacement surgery. But, according to FDA officials, the product is also being marketed for other uses by DePuy through an online brochure.
The FDA has given DePuy 15 working days to submit a plan of action for correcting the violations for TruMatch and Corail. In a statement, DePuy officials said they are reviewing the FDA letter and will respond to the agency's request for information.