BEUDAMED
    FDA Enforcement Class II Terminated

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    Recall: Z-1744-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1744-2015
    Event ID
    71365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BIOMET FRANCE S.A.R.L.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 14, 2015
    Classification Date
    June 10, 2015
    Termination Date
    October 27, 2015
    Address
    plateau de lautagne, valence cedex 9, Valence Cedex 9, N/A, N/A, France

    Description

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    Reason

    The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.

    Code Info

    Catalog number: 419500 Lot number: 0101296012

    Distribution

    Nationwide distribution to MD only

    Quantity

    3