BEUDAMED
    FDA Recall Terminated

    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

    Recall: Z-0458-2022 · Initiated November 22, 2021

    Recall

    Recall Number
    Z-0458-2022
    Event Number
    89184
    Firm
    Uromedica Inc.
    FEI Number
    3003477176
    Product Code
    EZY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 22, 2021
    Terminated
    August 11, 2023
    Address
    1840 Berkshire Ln N, Plymouth, MN, 55441-3723

    Description

    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

    Reason

    The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.

    Action

    Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.

    Quantity

    18 devices