BEUDAMED
    FDA Recall Terminated

    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.

    Recall: Z-1021-2015 · Initiated December 15, 2014

    Recall

    Recall Number
    Z-1021-2015
    Event Number
    70019
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HXW
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    December 15, 2014
    Posted
    January 28, 2015
    Terminated
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.

    Reason

    Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.

    Action

    An Urgent Notice: Medical Device Recall, dated December 19, 2014, was sent to end users and sales consultants that described the product, problem, and action to be taken. End users/sales staff were requested to immediately stop use and remove affected product from inventory. Customers were asked to call and obtain a Return Authorization Number, and complete and return the Verification Section of the letter along with the devices to Synthes per the instructions provided. Questions should be directed to 610-719-5450 or your local DePuy Synthes sales consultant.

    Distribution

    Worldwide Distribution -- US and Canada.

    Quantity

    973