DePuy suspends distribution of custom devices following FDA warning

Posted on : 23 January 2012

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;