BEUDAMED
    FDA Enforcement Class II Terminated

    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

    Recall: Z-1749-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1749-2015
    Event ID
    71297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 18, 2015
    Classification Date
    June 10, 2015
    Termination Date
    October 30, 2015
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

    Reason

    The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

    Code Info

    Lot Number S29

    Distribution

    US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.

    Quantity

    45 units