The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
Millar Instruments Inc. pulled more than 1,000 of its angiographic catheters over fears that one of its components could contain debris, while H&P Industries Inc. recalled all of its Providine Prep antiseptic pads after the company discovered a serious infection-causing bacteria on the products.
The FDA has not yet classified either recall, but both companies said that use of the affected products could result in death.
