Events

Recall of Helioseal F Sealant

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

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
    72290
  • Event Risk Class
    Class 2
  • Event Number
    Z-0213-2016
  • Event Initiated Date
    2015-10-07
  • Event Date Posted
    2015-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140485
  • 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
    Sealant, pit and fissure, and conditioner - Product Code EBC
  • Reason
    A defect occurred in the production process of helioseal f sealant; the particles in the faulty component seem to be larger than the size defined in the formula. this results in difficulties during extrusion of the material.
  • Action
    Ivoclar Vivadent sent an Urgent Medical Device Recall Letter dated October 7, 2015, with Response Forms via Certified Mail, Return Receipt Requested. Dealers were also contacted via telephone/e-mail and informed to expect the letter. Dealers are requested to check their stock and return any affected material for credit, plus notify their customers of the recall. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.

Device

Helioseal F Sealant
  • Model / Serial
    Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
  • Product Description
    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
  • Manufacturer
    Ivoclar A. G.

Manufacturer

Ivoclar A. G.