BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0031-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0031-2014
    Event ID
    65952
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    July 16, 2013
    Classification Date
    October 21, 2013
    Termination Date
    August 26, 2014
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    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.

    Code Info

    RT040R, all lot numbers

    Distribution

    Nationwide Distribution.

    Quantity

    217