BEUDAMED
    FDA Enforcement Class II Terminated

    Thread-like wire marker

    Recall: Z-1200-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1200-2021
    Event ID
    87317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Somatex Medical Technologies GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 17, 2021
    Initiation Date
    February 3, 2021
    Classification Date
    March 10, 2021
    Termination Date
    January 13, 2022
    Address
    Hohenzollerndamm 150-151, Berlin, N/A, Germany

    Description

    Thread-like wire marker

    Reason

    This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

    Code Info

    Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301.

    Distribution

    Domestic: Mo, NJ, OH

    Quantity

    196 pieces