Irvine, CA, United States
Axonics Modulation Technologies, Inc. recalls
1 recall recorded since 2018, most recently on 3 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 June 2021
- Terminated
- 20 April 2022
- Reason
- Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2077-2021
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.