FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.
The agency will work to ensure safe and effective sterilization amid the shutdown of a large contract sterilization facility and the planned shutdown of another.
The system is used for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
The agency aims to enhance medical device safety net and focus on several women's health devices.
Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration11.21.18