BEUDAMED
    FDA Enforcement Class II Terminated

    BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.

    Recall: Z-1133-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1133-2014
    Event ID
    67475
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heraeus Kulzer, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 12, 2014
    Initiation Date
    February 10, 2014
    Classification Date
    March 4, 2014
    Termination Date
    June 18, 2014
    Address
    300 Heraeus Dr, South Bend, IN, 46614-2557, United States

    Description

    BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.

    Reason

    As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C

    Code Info

    Part #1010-451 Lot #13121434

    Distribution

    USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV

    Quantity

    812 units (gallons)