BEUDAMED
    FDA Recall Terminated

    Zimmer Spine Ardis Inserter, Rx, non-sterile

    Recall: Z-0594-2013 · Initiated November 12, 2012

    Recall

    Recall Number
    Z-0594-2013
    Event Number
    63683
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 12, 2012
    Posted
    December 22, 2012
    Terminated
    February 25, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Spine Ardis Inserter, Rx, non-sterile

    Reason

    Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks

    Action

    Zimmer Spine, sent a "MEDICAL DEVICE CORRECTION" memo dated November 12, 2012 to all consignees / customers describing product, problem and actions to be taken including revised surgical technique. Beginning the week of December 17, 2012, Zimmer began the immediate retrieval of the affected units as a Class I recall. December 20, 2012 nation wide press outlining the recall was issued. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at [email protected].

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.

    Quantity

    315 (172 in USA)