FDA Device recall Z-2077-2021
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
- FDA Device
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476 by Axonics Modulation Technologies, citing lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2077-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-03 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Axonics Modulation Technologies |
| Distribution | US |
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
Identifiers
| code_info | Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2077-2021%22
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