Events

Recall of Dentsply Cavitron Scalers & Air Polishing Units, water filters

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

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
    13423
  • Event Initiated Date
    2012-08-31
  • 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
    The manufacturer advises that a limited number of water filters may develop leaks. the water filters are installed on the external water supply hoses.
  • Action
    Product to be exchanged

Device

Dentsply Cavitron Scalers & Air Polishing Units, water filters

Manufacturer

Dentsply LLC, Professional Division