Johnson & Johnson Recalls All Unused Custom Implants At FDA's Request

Johnson & Johnson’s subsidiary, DePuy Orthopaedics, has recalled all unused custom hip and joint implants following last year’s warning from the U.S. Food and Drug Administration (FDA) over safety concerns. This recall notice was published August 24, 2012. DePuy had agreed to stop manufacturing the devices in January 2012 after receiving the FDA warning stating that the devices were being sold without FDA’s approval. It is not known how many unused devices this recall will involve. Although DePuy made the case their devices were “exempt” from FDA’s approval because, in DePuy’s view, they had been previously approved by the FDA and were modified only by a doctor’s prescription, the FDA took exception noting the devices required clinical trials and approved marketing applications. The FDA also stated DePuy used “poor quality control” in the manufacture of the devices. In August 2010, the DePuy ASR metal-on-metal hip implant used throughout the world was recalled. The recall involved approximately 93,000 hip replacement and re-surfacing devices, the failure of which caused patients to require revision surgeries. 8,300 DePuy hip implants have been sold since 1999. In the U.S., more than 8,000 lawsuits have been filed against DePuy, and the first of these are just beginning to be settled.