BEUDAMED
    FDA Recall Terminated

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194

    Recall: Z-1838-2020 · Initiated April 13, 2020

    Recall

    Recall Number
    Z-1838-2020
    Event Number
    85450
    Firm
    Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein
    FEI Number
    3002808636
    Product Code
    EIH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 13, 2020
    Terminated
    January 22, 2021

    Description

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194

    Reason

    Restorations crack during the sintering process.

    Action

    Ivoclar Vivadent issued notification via email to distributors on 4/13/20 via email and email and priority mail to Dentists, labs on by 4/20/20. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Check your stock and immediately segregate any material marked with the affected lot numbers. 2. Discard product. 3. Complete, sign and return the attached acknowledgement form and email to [email protected]. 4. Credit will be issued for all returned acknowledgment forms Questions contact Ivoclar Vivadent Customer Service at 800-533-6825 or your Patterson representative.

    Distribution

    US Nationwide distribution.

    Quantity

    332