BEUDAMED
    FDA Enforcement Class II Terminated

    Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

    Recall: Z-0797-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0797-2016
    Event ID
    73069
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    January 8, 2016
    Classification Date
    February 10, 2016
    Termination Date
    November 16, 2016
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

    Reason

    There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

    Code Info

    BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023.

    Distribution

    Worldwide Distribution -- US, Spain, Italy, and Australia.

    Quantity

    36 units