BEUDAMED
    FDA Recall Terminated

    Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

    Recall: Z-1832-2013 · Initiated May 30, 2013

    Recall

    Recall Number
    Z-1832-2013
    Event Number
    65568
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    GFC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 30, 2013
    Posted
    July 31, 2013
    Terminated
    September 19, 2013
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

    Reason

    When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.

    Action

    Exactech sent a" Important Product Recall Notice" dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to Immediately cease distribution or use of the products. Extend this information to your accounts that may have this product in their possession. Verify if you have any of the subject ARTICULATE DRIVER (catalog number 181-00-04) in the specified lots. FAx back the attached form. Further questions please call 1-800-392-2832.

    Distribution

    US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX

    Quantity

    57