Events

Recall of Bluephase Style Light Pin Point Probe 62 mm

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
    67998
  • Event Risk Class
    Class 2
  • Event Number
    Z-1740-2014
  • Event Initiated Date
    2014-04-14
  • Event Date Posted
    2014-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126760
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • Reason
    A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
  • Action
    lvoclar Vivadent, Inc. sells the affected medical device through Dental Dealer partners (initial consignees) who in turn sell directly to the dentist's office. In this case, lvoclar Vivadent, Inc. handled direct drop shipment of the device to end user dental offices in 80% of the cases. Where lvoclar Vivadent has direct shipment information available, dentist offices will be notified directly. The Dental Dealer partners will be notified of this recall and asked to cooperate and provide name and address listings for all dental office customers where they have shipped the Pin Point probe. The dealer will also be given a customer communication to send directly to the dentists purchasing the device.

Device

Bluephase Style Light Pin Point Probe 62 mm
  • Model / Serial
    Reference number 636241, all lots
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Nationwide and the country of Canada.
  • Product Description
    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light || Ultraviolet activator for polymerization for use during dental curing.
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.