BEUDAMED
    FDA Recall Terminated

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    Recall: Z-1870-2008 · Initiated May 21, 2008

    Recall

    Recall Number
    Z-1870-2008
    Event Number
    48447
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    FWX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 21, 2008
    Posted
    September 16, 2008
    Terminated
    April 30, 2012
    Address
    4725 Calle Quetzal, Camarillo, CA, 930129101

    Description

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    Reason

    Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient.

    Action

    The Notification was sent via FedEx overnight on 05/27/2008 to the Director of Risk Management, Director of Biomedical, and Director of Operating Room at each institution with a table. The Safety Notification included: (1) Revised Instructions for Use that include (a) Improved instructions for the attachment of the clamps, and (b) Instructions for the use of new safety straps to provide a fail-safe attachment means. (2) A hang tag for labeling the devices. (3) A reply card indicating that the label has been attached to the table. Customers have been instructed in the proper adjustment of the clamps for the universal table as well as in the use of the safety straps. Customers have also been provided with a hang tag that reinforces the use of the safety straps when attaching the universal table. An additional copy of the notification will be provided to the sales representatives responsible for these hospitals. Included in these packets are instructions for the sales representatives to visit each hospital and provide hands-on training to the operating room personnel regarding proper attachment of the universal table, use of the clamps, and use of the straps. If you have questions, contact Medacta USA at 1-800-901-7836.

    Distribution

    Nationwide to CA, CO, FL, ID, NV, TX & UT; Worldwide to: Belgium, France, Germany, Italy & Switzerland

    Quantity

    20 Units