BEUDAMED
    FDA Recall Terminated

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    Recall: Z-1478-2008 · Initiated November 27, 2007

    Recall

    Recall Number
    Z-1478-2008
    Event Number
    46781
    Firm
    Allen Medical Systems, Inc. One Post Office Square
    FEI Number
    1221538
    Product Code
    CCX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 27, 2007
    Posted
    August 20, 2008
    Terminated
    August 26, 2008
    Address
    Acton, MA, 01720

    Description

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    Reason

    Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.

    Action

    Allen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded.

    Distribution

    MA, MS

    Quantity

    2