J&J's DePuy to stop selling all custom devices in response to FDA warning

January 19, 2012 by MassDevice staff

Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components.

Depuy Orthopaedics logo

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics decided to stop selling all custom fitted devices in response to an FDA warning following an inspection of the Warsaw, Ind.-based company's facilities.

This week the FDA's Centers for Devices & Radiological Health released a letter warning Depuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.

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