Events

Recall of NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-00502-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00502-1
  • 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
    Ndi determined that drms spheres from lot c102061501 may break apart at the mid-point where the two halves of the sphere are sealedtogether, either during installation onto reference arrays or surgical tools (i.E., when threading them onto posts), or any time during a surgical procedure.One failure of this nature has been reported, with no report of injury or death.
  • Action
    Life Healthcare is requesting their customers to quarantine any affected stock. Life Healthcare will provide replacement stock where required. This action has been closed-out on 10/08/2016.

Device

NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-g...
  • Model / Serial
    NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)Lot C102061501ARTG Number: 182255
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd