BEUDAMED
    FDA Recall Terminated

    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

    Recall: Z-0655-2012 · Initiated November 16, 2011

    Recall

    Recall Number
    Z-0655-2012
    Event Number
    60435
    Firm
    Allen Medical Systems, Inc. One Post Office Square
    FEI Number
    1221538
    Product Code
    CCX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 16, 2011
    Posted
    January 11, 2012
    Terminated
    November 14, 2012
    Address
    Acton, MA, 01720

    Description

    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

    Reason

    C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity

    Action

    Allen Medical Systems sent a Urgent Medical Device Recall Notification dated November 18, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Allen Medical will provide packaging materials and instructions for returning your device for repair at not cost to you. Each unit will be repaired and tested. Devices which pass all testing will be returned to the field. For further questions please call 888-521-4277 ext. 4280

    Distribution

    Worldwide Distribution -- USA (nationwide ) and the countries of Africa, Australia, Bulgaria, China, Germany, India, Istanbul, France, Greece, New Zealand, Saudi Arabia,Singapore, Spain, Taiwan and Japan.

    Quantity

    83 units