Events

Recall of Pulp Canal Sealer EWT Standard, Pulp Canal Sealer EWT Bulk Powder Refill (Root canal sealing material)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ormco 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-2013-RN-00284-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00284-1
  • 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
    Complaints were received stating that the pulp canal sealer ewt standard product was setting too quickly. investigation has determined that the affected material does indeed set 3 hours faster than specified in the directions for use which provide for a work/set time of 6 hours or greater.
  • Action
    Customers are requested to return any affected stock to Ormco Pty Ltd. Replacement stock will be provided.

Device

Pulp Canal Sealer EWT Standard, Pulp Canal Sealer EWT Bulk Powder Refill (Root canal sealing mate...
  • Model / Serial
    Pulp Canal Sealer EWT Standard, Pulp Canal Sealer EWT Bulk Powder Refill (Root canal sealing material)Product codes: 24746 and 24745Lot number: 1-2333ARTG: 120315
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd