BEUDAMED
    FDA Recall 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 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1479-2015
    Event Number
    70488
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    FTY
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 5, 2015
    Posted
    April 21, 2015
    Terminated
    June 15, 2015
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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.

    Action

    SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990.

    Distribution

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

    Quantity

    5 devices