Axonics Modulation Technologies, Inc. Recall 88141
Description: BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Axonics Modulation Technologies, Inc. Recall 88141 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2077-2021 |
| Event ID | 88141 |
| Event Description | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476 |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 2,702 units |
| Recall Reason | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized |
| Device Classification | 20210721 |
| Device Code Info | Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA |
| Center Classification Date | 20210715 |
| Recall Initiation Date | 20210603 |
| Recalling Firm | Axonics Modulation Technologies, Inc. |
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