BEUDAMED
    FDA Recall Terminated

    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.

    Recall: Z-0659-2013 · Initiated September 20, 2012

    Recall

    Recall Number
    Z-0659-2013
    Event Number
    63559
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 20, 2012
    Posted
    January 9, 2013
    Terminated
    April 23, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.

    Reason

    Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant

    Action

    Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.

    Distribution

    USA nationwide; Europe, Sweden

    Quantity

    170