BEUDAMED
    FDA Recall 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 · Initiated June 3, 2021

    Recall

    Recall Number
    Z-2077-2021
    Event Number
    88141
    Firm
    Axonics Modulation Technologies, Inc.
    FEI Number
    3002968685
    Product Code
    LNM
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 3, 2021
    Terminated
    April 20, 2022
    Address
    26 Technology Dr, Irvine, CA, 92618-2380

    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

    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

    Distribution

    US nationwide distribution.

    Quantity

    2,702 units