Orthopedic device firm DePuy, a Johnson & Johnson Company, of Warsaw Ind., is reportedly marketing two systems it manufactures in violation of the Federal Food, Drug, and Cosmetic Act, according to a warning letter dated Aug. 19, 2010, that the FDA sent to David Floyd, President of DePuy Orthopaedics Inc.
By reviewing information at DePuys website, the Office of Compliance of the Center for Devices and Radiological Health identified problems with how two products were being marketed the TruMatch Personalized Solutions System, which is used to produce custom surgical guides, and the Corail Hip System, for hip arthroplasty surgery.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law, the FDAs Timothy A. Ulatowski, director of the Office of Compliance of the Center for Devices and Radiological Health, wrote in the letter sent to Floyd. He also mentioned that the device is misbranded.
According to Ulatowskis letter, the DePuy Corail AMT Hip Stem is indicated for cementless use only, but DePuy is reportedly promoting the device for osseointegration, which, whether explicitly or implicitly, is a major change or modification in the intended use of your device
Ulatowski wrote that such changed use requires a new premarket notification.
DePuy Orthopaedics said in a statement provided to ORTHOSuperSite.com, DePuy Orthopaedics has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the marketing of TruMatch Personalized Solutions System and the Corail Hip System. We are reviewing the letter to understand the FDAs concerns and will respond to their request for information.
The FDA has requested two actions from DePuy Orthopaedics. For the TruMatch System, information should be submitted to obtain approval or clearance for the device, which the FDA will then use to evaluate whether the product may be legally marketed, according to the letter.
Additionally, as stated in the same letter, FDA requests that DePuy Orthopaedics, Inc. immediately cease marketing the Corail Hip System for unapproved uses such as those described above. You should take prompt action to correct the violations listed in the letter.
DePuy was given 15 days to notify Ulatowskis office of specific steps taken to correct the two violations and how it plans to prevent similar violations from happening in the future.