Recall Z-2077-2021— Axonics Modulation Technologies, Inc.

Name: FDA recall Z-2077-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-03

Class II · Terminated

Class II FDA medical device recall by Axonics Modulation Technologies, Inc., initiated 2021-06-03, terminated 2022-04-20. FDA's recall record names no specific 510(k) clearance for this event. Product: BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476. Reason: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized.

Recalling firm: Axonics Modulation Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-06-03
Terminated: 2022-04-20
Firm location: Irvine, CA, United States

Product description

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Reason for recall

Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

Data sourced from openFDA. This site is unofficial and independent of the FDA.