Events

Recall of VDR Proximal Targeting Guide in Acu-Loc 2 Loan sets

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical & Optical Instruments 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-00162-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00162-1
  • 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
    There is a chance that the vdr proximal targeting guide will crack and/or break after repeated use in surgery. if the instrument breaks, it may result in pieces not being removed from the patient and therefore causing prolonged surgery, soft tissue damage, histological and/or allergic reaction.
  • Action
    Medical and Optical are advising users that all affected devices are being replaced with "black" guides unaffected by this issue.

Device

VDR Proximal Targeting Guide in Acu-Loc 2 Loan sets
  • Model / Serial
    VDR Proximal Targeting Guide in Acu-Loc 2 Loan setsPart Numbers: 80-0700 (yellow), 80-0702 (yellow), 80-0704 (yellow), 80-0701 (yellow), 80-0703 (yellow), 80-0705 (yellow)Manufactured prior to 28 August 2012ARTG Number: 97308
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd