BEUDAMED
    FDA Recall 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 · Initiated February 4, 2013

    Recall

    Recall Number
    Z-0812-2013
    Event Number
    64272
    Firm
    Ultradent Products, Inc.
    FEI Number
    1718912
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 4, 2013
    Posted
    February 13, 2013
    Terminated
    May 30, 2013
    Address
    505 W 10200 S, South Jordan, UT, 84095-3935

    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.

    Action

    Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.

    Distribution

    Nationwide Distribution

    Quantity

    100 cartridges