BEUDAMED
    FDA Recall Terminated

    3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    Recall: Z-0390-2014 · Initiated July 22, 2013

    Recall

    Recall Number
    Z-0390-2014
    Event Number
    66666
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    July 22, 2013
    Posted
    November 26, 2013
    Terminated
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    Reason

    All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

    Action

    Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Canada.

    Quantity

    40248