BEUDAMED
    FDA Enforcement Class II Terminated

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    Recall: Z-1546-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1546-2015
    Event ID
    71061
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 6, 2015
    Initiation Date
    April 10, 2015
    Classification Date
    April 29, 2015
    Termination Date
    June 29, 2015
    Address
    1111 Autoroute Chomedy, Laval, N/A, Canada

    Description

    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.

    Reason

    The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.

    Code Info

    Lot 290609-01

    Distribution

    Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.

    Quantity

    9 units (5 units in the US and 4 units international)