Events

Recall of Device Recall Zenostar MT Color A3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ivoclar Vivadent, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74320
  • Event Risk Class
    Class 2
  • Event Number
    Z-0023-2017
  • Event Initiated Date
    2016-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147150
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powder, porcelain - Product Code EIH
  • 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.

Device

Device Recall Zenostar MT Color A3
  • Model / Serial
    Lot No: U49683, exp date: Nov 2 2017; U49656, exp date: Nov 2 2017; and U39116, exp date: Sep 17 2017
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Zenostar MT Color A3 60ml, art. no. 681052. || Product Usage: || For coloring dental porcelain
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.