Events

Recall of Kerr Herculite Ultra Composite Restoratives

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    17206
  • Event Initiated Date
    2014-08-28
  • 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: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
  • Reason
    The manufacturer has received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. investigation of the retained and returned product confirmed that the composite does not extrude easily. additionally, any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.
  • Action
    Product to be returned to supplier

Device

Kerr Herculite Ultra Composite Restoratives
  • Model / Serial
    Model: Part Numbers: 35166, 34348, 34448, 34338, Affected: Specific lots
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation