BEUDAMED
    FDA Enforcement Class II Terminated

    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

    Recall: Z-0751-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0751-2013
    Event ID
    64129
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greatbatch Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    January 16, 2013
    Classification Date
    January 30, 2013
    Termination Date
    September 16, 2014
    Address
    2300 Berkshire Ln N, Minneapolis, MN, 55441-4575, United States

    Description

    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

    Reason

    Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45¿ product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.

    Code Info

    All lots

    Distribution

    Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.

    Quantity

    913