FDA WARNING_LETTER - DePuy Orthopaedics, Inc. - June 07, 2011

On December 8, 2011, the FDA issued a Warning Letter to DePuy Orthopaedics, Inc. following an inspection from May 10 to June 7, 2011, at their Warsaw, Indiana facility. The inspection revealed that several of DePuy's orthopedic devices, including components of the PFC Sigma Knee System, Agility Total Ankle Prosthesis, Global Advantage Shoulder System, TriFlange Acetabular Cups, and Femoral heads, were adulterated and misbranded.

The devices were found to be adulterated under section 501(f)(1)(B) of the Act because DePuy lacked approved Premarket Approval (PMA) applications or Investigational Device Exemptions (IDE). They were also misbranded under section 502(o) for failure to submit 510(k) premarket notifications. The FDA identified 14 specific devices or modifications that lacked premarket clearance or approval, or required new 510(k)s or PMA Supplements due to modifications impacting safety and effectiveness.

DePuy's claim that these devices were "custom devices" was rejected by the FDA. The agency stated that the devices did not meet the criteria for custom devices under section 520(b) of the Act and 21 CFR 812.3(b), as they did not necessarily deviate from generally available devices, were not