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The FDA has issued a recall of Blackstone Medical’s ICON Modular Fixation System — a collection of components allowing the surgeon to assemble a construct that includes screws, connectors and rods — because components in the system may fail after the devices have been implanted. The product has been marketed since June 2005.
The FDA will rely on a panel of outside medical experts in cardiac electrophysiology to help determine the safety and effectiveness of defibrillators already on the market, particularly in cases when a device is recalled.
The FDA recalled additional codes of the Composix Kugel Mesh Patch, which is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery March 31.
Iceland-based prosthetics maker Ossur announced a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee prosthetic device.