Events

Recall of Device Recall IPS Empress Universal Glaze Spray

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
    71636
  • Event Risk Class
    Class 2
  • Event Number
    Z-2265-2015
  • Event Initiated Date
    2015-07-09
  • Event Date Posted
    2015-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138435
  • 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
    Complaints were received of coarse particles in the glazed surface of ips e.Max ceram restorations. a basic component of the glass contains a higher number of large grain sizes than usual.
  • Action
    Ivoclar Vivadent sent an URGENT MEDICAL DEVICE RECALL Letter (dated 7/8/2015) and Response Form to affected customers via Certified Mail Return Receipt Request. The letter identified the affected product, problem and actions to be taken. Customers were instructed to notify dentists of the recall and request return of product. A notification letter was sent to dentists on 7/24/2015 requesting they destroy the product on hand (if any) and report back to Ivoclar Vivodent. For questions in the United States contact US Headquarters Ivoclar Vivadent Customer Services at 1-800-533-6825.

Device

Device Recall IPS Empress Universal Glaze Spray
  • Model / Serial
    Batch U15124
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the states of: PA, IN, IA and SC.
  • Product Description
    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.