Z-2077-2021Class II

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2...

Name: Z-2077-2021 BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2...
Creator: Axonics Modulation Technologies, Inc.
Published: 2021-06-03
License: https://open.fda.gov/license/

Axonics, Inc. / initiated 2021-06-03 / Terminated / root cause: manufacturing process

FDA source

Axonics Modulation Technologies, Inc. began a recall of BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476 on 2021-06-03. FDA classified it as Class II and gives the reason as "Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2077-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-03
Posted: 2021-07-15
Terminated: 2022-04-20
Recalling firm: Axonics, Inc.
Product: BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Product code: LNM Agent, Bulking, Injectable For Gastro-Urology Use
Reason for recall: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Root cause tag: manufacturing process
FDA 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 [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
Quantity in commerce: 2,702 units
Distribution: US nationwide distribution.
Product codes and lots: Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2077-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2077-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-15

Product code LNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)