BEUDAMED
    FDA Enforcement Class II Terminated

    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23

    Recall: Z-2534-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2534-2020
    Event ID
    85894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dufner Instrumente GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 3, 2020
    Classification Date
    July 7, 2020
    Termination Date
    January 21, 2021
    Address
    Fohrenstr. 9, Tuttlingen, N/A, Germany

    Description

    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23

    Reason

    Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury

    Code Info

    Lot Numbers: 8170368 and 8180673

    Distribution

    IL

    Quantity

    30 units