Request Legal Help Now - Free


FDA Warning to DePuy Orthopaedics

Were you looking for DePuy ASR Hip lawsuits?

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.

Legal Help

If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Aug-25-10


Fields marked * are mandatory. Please read our comment guidelines before posting.


Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request Legal Help Now! - Free