J&J receives FDA warning, issues recall

The agency says sales of 2 orthopedic products violated federal rules.

By TheStreet Staff Aug 24, 2010 2:15PM

TheStreetBy Andrea Tse, TheStreet

 

Johnson & Johnson (JNJ) received a warning letter from the U.S. Food and Drug Administration for allegedly violating FDA rules by marketing two orthopedic products without approval, the agency said.

 

The products in question are the TruMatch Personalized Solutions System, a knee replacement device, and the Corail Hip System.

 

"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," the FDA said in the letter to J&J. The agency said the Corail Hip System was also being marketed for "unapproved uses."

 

Both products are being sold by J&J's DePuy Orthopaedics unit.

The FDA has asked DePuy Orthopaedics to "immediately cease marketing the Corail Hip System for unapproved uses" and said it will evaluate the information J&J submits for TruMatch to determine whether the product may be legally marketed.

 

This week, it was also reported that J&J, which has in the past recalled popular products such as Tylenol, recalled millions of disposable 1-Day Acuvue contact lenses in Asia and Europe.

 

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