BEUDAMED
    FDA Recall Terminated

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

    Recall: Z-0717-2017 · Initiated November 9, 2016

    Recall

    Recall Number
    Z-0717-2017
    Event Number
    75620
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 9, 2016
    Terminated
    June 18, 2018
    Address
    175 Pineview Dr, Amherst, NY, 14228-2231

    Description

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, 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.

    Action

    Ivoclar Vivadent sent and URGENT - MEDICAL DEVICE RECALL Letters (dated 11/07/2016) and Recall Response Forms to customers via Certified Mail-Return Receipt Requested. The letter identified the affected product, problem and actions to be taken. Customers were advised to return all affected products in stock. For questions contact Ivoclar Vivadent Customer Service at 800-533-6825.

    Distribution

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

    Quantity

    US: 4659 units, Canada: 729 units