FDA recall Z-2077-2021

Axonics Modulation Technologies, Inc. · Class II · device

Product

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

Distribution

US nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-06-03
Report date
2021-07-21
Termination date
2022-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2021