BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1472-2014 · Initiated March 5, 2014

    Recall

    Recall Number
    Z-1472-2014
    Event Number
    67803
    Firm
    Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
    FEI Number
    3000327445
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 5, 2014
    Posted
    April 18, 2014
    Terminated
    May 19, 2014

    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.

    Action

    There is an error on the outside label of the implant. The length was mistaken on the label. It was indicated 245mm instead of 338mm. It has to be clarified that the Fassier-Duval implant is provided with two labels, one that is outside the tube used for packaging and one inside the tube.

    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