BEUDAMED
    FDA Recall Terminated

    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

    Recall: Z-0031-2014 · Initiated July 16, 2013

    Recall

    Recall Number
    Z-0031-2014
    Event Number
    65952
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 16, 2013
    Posted
    October 21, 2013
    Terminated
    August 26, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

    Reason

    Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.

    Action

    A letter dated July 16, 2013 was sent requesting users to review the new instructions for use in their entirety, sign the attached Hospital Acknowledgment form and return to Aesculap. An Aesculap representative would be in contact to provide an in-service regarding the process for set-up of the Sterile Cover and required Functional Check. Discontinuation of use and repair of the device was recommended if the joints did not move freely or if the set position drifts during the Functional Check.

    Distribution

    Nationwide Distribution.

    Quantity

    217