Events

Recall of Device Recall Fusio Liquid Dentin

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

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
    61239
  • Event Risk Class
    Class 2
  • Event Number
    Z-1115-2012
  • Event Initiated Date
    2010-08-19
  • Event Date Posted
    2012-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107638
  • 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
    Material, tooth shade, resin - Product Code EBF
  • Reason
    A recall was initiated because pentron clinical has confirmed that the fusio liquid dentin is not as flowable as ideally expected.
  • Action
    Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Fusio Liquid Dentin
  • Model / Serial
    Lot Numbers: 3487864, 3491581
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
  • Product Description
    Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. || Product Usage: || The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA