BEUDAMED
    FDA Enforcement Class II Terminated

    Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

    Recall: Z-0037-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0037-2017
    Event ID
    74320
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    May 27, 2016
    Classification Date
    October 4, 2016
    Termination Date
    June 14, 2018
    Address
    175 Pineview Dr, N/A, Amherst, NY, 14228-2231, United States

    Description

    Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

    Reason

    The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

    Code Info

    Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017

    Distribution

    US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

    Quantity

    5 units