Events

Recall of Dentsply Fluorocore 2+ Fast Set

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Dentsply Caulk.

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
    15031
  • Event Initiated Date
    2013-07-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Dentsply Sirona (NZ) Limited, C/- Lowndes Jordan, Level 15, PWC Tower, 188 Quay Street, Auckland 1010
  • Reason
    Manufacturer have advised that two lots (batches) of fluorocore may exhibit faster setting characteristics than is normal for these products. while it has ben determined that there is no health risk to either patients or dental professionals associated with these products, the identified lot numbers do not meet the manufacturer's standards for product quality.
  • Action
    Product to be returned to supplier

Device

Dentsply Fluorocore 2+ Fast Set
  • Model / Serial
    Model: 612402, Affected: 1209242 and 120904
  • Manufacturer
    Dentsply Caulk

Manufacturer

Dentsply Caulk