BEUDAMED
    FDA Enforcement Class III Terminated

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    Recall: Z-0812-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0812-2013
    Event ID
    64272
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    February 4, 2013
    Classification Date
    February 13, 2013
    Termination Date
    May 30, 2013
    Address
    505 W 10200 S, South Jordan, UT, 84095-3935, United States

    Description

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    Reason

    Incorrect packaging of regular set and fast set cartridges.

    Code Info

    Lot No. B7DS3

    Distribution

    Nationwide Distribution

    Quantity

    100 cartridges