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