Events

Recall of Brainlab Offset Cup Impactor Universal

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab 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-00066-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00066-1
  • 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
    It has been detected that, when the device is reprocessed according to the instructions in the current brainlab cleaning, disinfection and sterilization guide (revision 4.9 and previous), the device may not achieve sterility. the required sterility assurance level (sal) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times.
  • Action
    Brainlab is providing the updated instructions for use to end users. This action has been closed-out on 18/07/2016.

Device

Brainlab Offset Cup Impactor Universal
  • Model / Serial
    Brainlab Offset Cup Impactor Universal Model Number: 52856, 52856AARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd