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Feds Warn J&J Unit Over Marketing Hip, Knee Devices

  • CNNMoney, Friday, August 27, 2010 10:36 AM
The Food and Drug Administration has issued a warning letter to Johnson & Johnson's DePuy Orthopaedics unit for selling hip and other joint products without without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act, Parija Kavilanz reports.

The FDA says will only evaluate whether the Corail Hip System and the TruMatch Personalized Solutions System, which makes artificial knee products, can be legally marketed to consumers after DePuy submits information for approval.

DePuy says it is "reviewing the letter to understand the FDA's concerns and will respond to their request for information."

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