BEUDAMED
    FDA Enforcement Class II 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 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1824-2020
    Event ID
    85284
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    February 25, 2020
    Classification Date
    April 29, 2020
    Termination Date
    May 19, 2021
    Address
    1717 W Collins Ave, N/A, Orange, CA, 92867-5422, United States

    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.

    Code Info

    Lot Numbers: 7402423, 7290257, 7451039

    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