BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0458-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0458-2022
    Event ID
    89184
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Uromedica Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 22, 2021
    Classification Date
    January 5, 2022
    Termination Date
    August 11, 2023
    Address
    1840 Berkshire Ln N, N/A, Plymouth, MN, 55441-3723, United States

    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.

    Code Info

    Lot numbers UM00794 and UM00817, UDI 00180668000106

    Distribution

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

    Quantity

    18 devices