Events

Recall of Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retrieval Kit.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nobel Biocare 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-2015-RN-00572-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00572-1
  • 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
    An internal investigation by the manufacturer showed that one dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • Action
    Nobel Biocare is requesting their customers to cease using the device and to return it to a Nobel Biocare subsidiary and receive a replacement instrument. If the affected instrument is a part of a kit, a Nobel Biocare Representative will contact the customer directly. This action has been closed-out on 03/03/2016.

Device

Abutment Retrieval Instrument Zirconia CC RP/WP This instrument can be included in Abutment Retri...
  • Model / Serial
    Abutment Retrieval Instrument Zirconia CC RP/WP Reference# 37882Batch# 96149 This instrument can be included in Abutment Retrieval Kit, Reference 37508, batches 814929, 815096, 815140, and 855021.
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd