July 21, 2021Medical DevicesFDA
Axonics Modulation Technologies, Inc. recalls BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,
Hazard: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized