J&J unit warned on hip and knee replacement systems

As if Johnson & Johnson (NYSE: JNJ) hasn't had enough issues this year, the FDA has dealt another blow to the company. According to an FDA warning letter, J&J unit DePuy Orthopaedics has marketed two products illegally. The products, Corail Hip System and TruMatch Personalized Solution System, have been marketed for unapproved uses.

The Corail Hip System should be used "to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components," the letter says. However, J&J's advertising brochure touts the system's osteointegration ability and promotes cement use with the product, both of which are unapproved.

On the other hand, the company's TruMatch system hasn't been approved at all. The system uses 3-D CT scan imagery to assist surgeons during knee replacements.

This week, J&J has already announced a contact lens recall, its ninth recall of the year, after added efforts to assure the public of its commitment to quality control. For now, DePuy has stated "reviewing the letter to understand the FDA's concerns and will respond to their request for information," according to the San Francisco Chronicle.

- check out the warning letter
- read the San Francisco Chronicle story
- here's more from Reuters

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