Events

Recall of AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fixation kit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by BioHorizons 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-2012-RN-01296-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01296-1
  • 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
    Biohorizons has found that the cleaning instructions may not be sufficient to remove residual contaminants after surgical use.
  • Action
    Affected lot numbers are identified in the customer letters sent by BioHorizons Australia. Re-clean the handle and sterilise prior to each use or subsequent re-use following the updated instructions provided with the customer letter. Early version of the AutoTac Handle that cannot be disassembled, cleaned and reassembled following the updated instructions are to be returned to BioHorizons Australia for replacement.

Device

AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fi...
  • Model / Serial
    AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fixation kit)Multiple lot numbers ARTG number: 132758
  • Manufacturer
    BioHorizons Australia Pty Ltd

Manufacturer

BioHorizons Australia Pty Ltd