BEUDAMED
    FDA Enforcement Class II 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 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0390-2014
    Event ID
    66666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    July 22, 2013
    Classification Date
    November 25, 2013
    Termination Date
    August 18, 2016
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    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.

    Code Info

    All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.

    Distribution

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

    Quantity

    40248