BEUDAMED
    FDA Enforcement Class II Terminated

    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    Recall: Z-1448-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1448-2014
    Event ID
    67675
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 16, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    April 10, 2014
    Termination Date
    April 23, 2014
    Address
    1111 Autoroute Chomedy, N/A, Laval, N/A, N/A, Canada

    Description

    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

    Reason

    The Male Components in this lot are made of material with lower strength than manufacturing specifications.

    Code Info

    Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

    Distribution

    Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.

    Quantity

    Total of 5 units (2 units in the US and 3 units in Germany)