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FDA tells DePuy to take joint replacements off the market

Posted on January 30th, 2012 No Comments

Recently, the FDA asked DePuy Orthopaedics to take several of their joint replacements off the market.  According to a letter from the agency, Johnson & Johnson and subsidiary DePuy sold 14 hip, knee, and joint replacements without proper approval.

The letter accuses DePuy of improperly marketing the devices and selling them without the necessary premarket approval.  Furthermore, the FDA was led to believe that DePuy intended to sell the replacements as custom devices, despite the fact that they did not tell regulators.

DePuy officials responded to the letter, arguing that their devices could avoid premarket approval through exemptions often provided to custom medical devices. ¬†However, FDA officials responded by saying that DePuy’s joint replacements could not be considered custom devices eligible for exemption because they are very similar to other DePuy products.

If you had a DePuy hip replacement implanted and subsequently experienced device failure, contact the DePuy lawsuit attorneys of Williams Hart at 800-761-3187 to learn more about taking legal action against DePuy Orthopaedics.

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