Events

Recall of Herculite Ultra Herculite Ultra Unidose Refill C4 Enamel, Herculite Ultra Unidose Refill A2 Enamel, Herculite Ultra Unidose Refill A3.5 Enamel, Herculite Ultra Refill Syringe A2 Enamel

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kerr Australia Pty Ltd.

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
    RC-2014-RN-00909-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-08-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00909-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Kerr corporation have received complaints that some herculite ultra products may be difficult to extrude or may not perform as intended. as a result, any composite extruded could exhibit signs of dryness and may not exhibit proper handling characteristics.
  • Action
    End users are advised that if they have any of the affected product in their inventory to immediately return it to Kerr Australia. This action has been closed-out on 01/03/2016.

Device

Herculite Ultra Herculite Ultra Unidose Refill C4 Enamel, Herculite Ultra Unidose Refill A2 Ename...
  • Model / Serial
    Herculite UltraProduct description/part number/lot number:Herculite Ultra Unidose Refill C4 Enamel351664650240,4718337, 4665811Herculite Ultra Unidose Refill A2 Enamel343484662093, 4678965, 4662092, 4667889, 4664839, 4681753, 4678966Herculite Ultra Unidose Refill A3.5 Enamel344484863611, 4861157, 4857439, 4786373, 4791140, 4791138, 4779744, 4734549 (Syringe)Herculite Ultra Refill Syringe A2 Enamel343384711654, 4672953, 4672288, 4734007, 4720200ARTG : 99818
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd