Recall Z-2077-2021 ยท LNM Agent, Bulking, Injectable For Gastro-Urology Use
Axonics Modulation Technologies, Inc.
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
| Date | Jun 3, 2021 |
| Status | Terminated |
| Reason | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized |
| Root cause | Material/Component Contamination |
| Action | On June 3, 2021 Axonics issued "Medical Device Recall" to all consignees via FedEx. In addition to informing consignees about the recalled product, the firm asked customers to take following actions: 1. Immediately review your inventory for the Lot No. specified in this notification and share this notice and Customer Response Form with appropriate staff. 2. If you further distributed this product, please notify those entities of this product recall. Please include a copy of this recall notification in your communication. 3. Quarantine and then discard any units of the impacted lots. Axoni |
| Quantity | 2,702 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.