BEUDAMED
    FDA Recall Terminated

    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

    Recall: Z-1456-2014 · Initiated January 30, 2014

    Recall

    Recall Number
    Z-1456-2014
    Event Number
    67499
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    GXL
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 30, 2014
    Posted
    April 14, 2014
    Terminated
    August 26, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

    Reason

    The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.

    Action

    Synthes sent an Urgent Notice: Field Safety Notification letter dated January 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions; Please see the Battery Powered Driver Users Manual for on-label procedures. You can access an electronic version of the Battery Powered Driver Users Manual by accessing the following : linlc http://www.synthes.com/pages/default.aspx. Click on North America Tab at the top of the screen, and then type Battery Powered Driver Users Manual in the search bar to download the Users Manual Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the graphic case has been forwarded to another facility, contact that facility. " Maintain a copy of this notice. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.

    Distribution

    Nationwide Distribution

    Quantity

    20081