BEUDAMED
    FDA Recall 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 · Initiated January 16, 2013

    Recall

    Recall Number
    Z-0751-2013
    Event Number
    64129
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 16, 2013
    Posted
    January 30, 2013
    Terminated
    September 16, 2014
    Address
    2300 Berkshire Ln N, Minneapolis, MN, 55441-4575

    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.

    Action

    Greatbatch sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 15, 2012 to all affected customers. The letter described the Reason For Recall, Risk to Health, and Instructions to Customers. Advised consignees to examine their inventory and quarantine the product in question. If they have further distributed the product to notify their customers and to complete and return the "Recall Response Form". Contact the firm at 1-763-951-8235 for questions relating to this notice.

    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