BEUDAMED
    FDA Recall Terminated

    Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.

    Recall: Z-1824-2020 · Initiated February 25, 2020

    Recall

    Recall Number
    Z-1824-2020
    Event Number
    85284
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    FEI Number
    2024312
    Product Code
    EMA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 25, 2020
    Terminated
    May 19, 2021
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.

    Reason

    An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.

    Action

    On February 25, 2020, Kerr sent a "Urgent: Medical Device Recall" letter via. USPS to affected consignees informing them about the recall associated with the Nexus Universal Trial Kit (#36990). In addition to informing consignees about the recall, the notification asked consignees to take the following actions: 1. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement. 2. KERR CORPORATION KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND EMAILING BACK THE ENCLOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION LETTER, REGARDLESS OF WHETHER YOU HAVE ANY PRODUCT IN YOUR INVENTORY 3. If you are an authorized Kerr Corporation distributor, we request that you identify those customers that may have been shipped the affected product and contact these customers to inform them of the issue.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, , MI, AZ, NC, KY, SC and the country of Netherlands.

    Quantity

    111 kits