FDA Warns Johnson & Johnson (JNJ)'s DePuy Orthopaedics, Inc. (JNJ) Unit on Custom Devices
1/19/2012 8:33:37 AM
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. 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.