Events

Recall of Excite F. DSC

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
    66359
  • Event Risk Class
    Class 2
  • Event Number
    Z-0376-2014
  • Event Date Posted
    2013-11-21
  • 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=122152
  • 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
    Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • Reason
    Ivoclar vivadent, inc. is recalling a lot of excite f dsc dental adhesive found to produce a blue green discoloration when used in combination with cements.
  • Action
    The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.

Device

Excite F. DSC
  • Model / Serial
    Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
  • Product Description
    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 || dental adhesive for restorations
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.