DePuy suspends distribution of custom devices following FDA warning
Published date : 23 January 2012
Article date : 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;
4. Agility Total Ankle Prosthesis talar components with stems 0.35 inches and longer;
5. Agility Total Ankle Prosthesis talar stems that are round in cross-section and taper downwards;
6. The Agility Total Ankle Prosthesis augments;
7. Global humeral stems 18 mm in diameter;
8. Global Humeral Stems shorter than 120 mm in length;
9. TriFlange Acetabular Cups with outer diameters greater than 66 mm;
10. TriFlange Acetabular Cups indicated for cemented use;
11. Femoral heads that include a 14/16 taper;
12. Femoral heads with offsets greater than +12;
13. Acetabular hip system 14/16 taper adapters; and
14. Adapters to Stryker hip components.
DePuy wrote in a statement that while the company believes it had complied with FDA requirements, it has decided not to provide custom devices at this time.
Read the full FDA warning letter here.
