Axonics Modulation Technologies, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2077-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 3, 2021

Date Posted: July 21, 2021

Recall Number: Z-2077-2021

Event ID: 88141

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,702 units

Code Information:

Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated