BEUDAMED
    FDA Enforcement Class II Terminated

    Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

    Recall: Z-2233-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2233-2020
    Event ID
    85613
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    May 5, 2020
    Classification Date
    June 2, 2020
    Termination Date
    July 15, 2022
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

    Reason

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Code Info

    UDI: (01)00887868310140; Lot Numbers: 136158 136158 143757 311626

    Distribution

    US nationwide distribution.

    Quantity

    3235 total