BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

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. Axonics will provide replacement product at no cost. 4. Complete and return the Customer Response Form within 10 working days to [email protected] so that we are assured you have received this important communication. 5. Report any adverse health consequences with the use of this product to Axonics or to the FDAs MedWatch Adverse Event Reporting program 6.If there are any questions, please email to [email protected] or call Axonics Customer Service at 1-877-929-6642 Action Taken by Axonics: 1. An alternate contract sterilization facility has already been qualified and is now being employed. 2. If you have any product from any of these lots, Axonics will replace the product at no cost. 3. Axonics will prioritize the replacement of product to customers affected by the recall and we respectfully request that you complete the Customer Response Form