BEUDAMED
    FDA Recall Terminated

    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

    Recall: Z-0555-2014 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0555-2014
    Event Number
    66873
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 20, 2013
    Posted
    December 20, 2013
    Terminated
    June 26, 2018
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

    Reason

    Screw inserters may not mate properly with hex interface of the screws.

    Action

    The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: [email protected]. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.

    Distribution

    US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

    Quantity

    13