BEUDAMED
    FDA Enforcement Class II Terminated

    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

    Recall: Z-1472-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1472-2014
    Event ID
    67803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 30, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    April 18, 2014
    Termination Date
    May 19, 2014
    Address
    1111 Autoroute Chomedy, N/A, Laval, N/A, N/A, Canada

    Description

    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

    Reason

    The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.

    Code Info

    Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13

    Distribution

    Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.

    Quantity

    48