Z-2077-2021 Class II Terminated
FDA device recall Z-2077-2021 was initiated by Axonics Modulation Technologies, Inc. on June 3, 2021 and is designated Class II. Reason for recall: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized The recall status is terminated (terminated April 20, 2022). Affected quantity: 2,702 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- June 3, 2021
- Termination Date
- April 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,702 units
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
Distribution Pattern
US nationwide distribution.
Code Information
Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA