Events

Recall of Sirona Dac Universal Combination Steriliser

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Nitram Dental A/S.

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
    20267
  • Event Initiated Date
    2016-06-23
  • 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: Sirona Dental Systems Ltd, Unit 21, 14-22 Tritoin Drive, Albany, North Shore, AUCKLAND
  • Reason
    Safety concern resulting from dac universal mk111 units that have been repaired using spare parts intended for mk11 units., the units possibly at risk are those that:, 1. fall within a determined serial number range and,, 2. where screws for the lid holder originally designed for the mk11 may have been used for a mk111 unit.
  • Action
    Product to be modified

Device

Sirona Dac Universal Combination Steriliser
  • Model / Serial
    Model: , Affected: Serial Nos:14000-99999;104000-199999; 202000-999999; B14000-B99999; B104000-B199999; B202000-B999999
  • Manufacturer
    Nitram Dental A/S

Manufacturer

Nitram Dental A/S