BEUDAMED
    FDA Enforcement Class II Terminated

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    Recall: Z-0719-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0719-2017
    Event ID
    75620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2016
    Initiation Date
    November 9, 2016
    Classification Date
    December 7, 2016
    Termination Date
    June 18, 2018
    Address
    175 Pineview Dr, N/A, Amherst, NY, 14228-2231, United States

    Description

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    Reason

    The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

    Code Info

    Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada and Australia

    Quantity

    US: 2090 units, Canada: 331 units, Australia: 465 units