BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2077-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2077-2021
    Event ID
    88141
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Axonics Modulation Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 21, 2021
    Initiation Date
    June 3, 2021
    Classification Date
    July 15, 2021
    Termination Date
    April 20, 2022
    Address
    26 Technology Dr, Irvine, CA, 92618-2380, United States

    Description

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

    Reason

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

    Code Info

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

    Distribution

    US nationwide distribution.

    Quantity

    2,702 units