BEUDAMED
    FDA Recall Terminated

    Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

    Recall: Z-0034-2017 · Initiated May 27, 2016

    Recall

    Recall Number
    Z-0034-2017
    Event Number
    74320
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    EIH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 27, 2016
    Terminated
    June 14, 2018
    Address
    175 Pineview Dr, Amherst, NY, 14228-2231

    Description

    Zenostar MT Color D2 60ml, art. no. 681063. 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.

    Action

    Wieland sent an Urgent Medical Device Recall Notification letters dated May 27, 2016, and Response Forms to their customers via courier service to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Segregate any affected materials immediately. Customers were asked to complete the attached Acknowledgment form and return it to Ivoclar Vivadent, Inc. by mail, fax or email as indicated on the form. For questions contact Ivoclar Vivadent Technical Customer Service at 800-533-6825.

    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

    40 units