Events

Recall of Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Alphabond Dental 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-2016-RN-00621-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00621-1
  • 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
    The product recall is implemented by the manufacturer, alphadent nv as a result of the cancellation of the company's ce certificate of conformity. alphadent nv has not received any injury reports relating either directly or indirectly to the medical devices (ceka attachments) subject to this recall. however, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, alphadent nv has decided to initiate a recall of the concerned medical devices manufactured from 13 september 2013 with batch number 13091 and subsequent batches.
  • Action
    Alphadent is advising users to inspect stock and quarantine any remaining stock for return or credit.

Device

Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Pre...
  • Model / Serial
    Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-ClipBatch Number: 13091 and subsequent Manufactured from 13 September 2013ARTG Number: 108721
  • Manufacturer
    Alphabond Dental Pty Ltd

Manufacturer

Alphabond Dental Pty Ltd