BEUDAMED
    FDA Enforcement Class II Terminated

    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.

    Recall: Z-1479-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1479-2015
    Event ID
    70488
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2015
    Initiation Date
    March 5, 2015
    Classification Date
    April 21, 2015
    Termination Date
    June 15, 2015
    Address
    500 Cummings Ctr Ste 3500, Beverly, MA, 01915-6516, United States

    Description

    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.

    Reason

    The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.

    Code Info

    Revision E

    Distribution

    US Nationwide Distribution in the states of TX, KS, CO, and MA

    Quantity

    5 devices