FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2077-2021
- Recalling firm
- Axonics Modulation Technologies, Inc.
- Product
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
- Status
- Terminated
- Initiated
- 2021-06-03
- Posted
- not on file
- Terminated
- 2022-04-20
- 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. Axonics will provide replacement product at no cost. 4. Complete and return the Customer Response Form within 10 working days to recall@axonics.com 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 recall@axonics.com 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
- Quantity
- 2,702 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
- 510(k) numbers
- not on file
- PMA numbers
- ["P170023"]
- Product code
- LNM
- Firm FEI
- 3002968685
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28