Events

Recall of Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)

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-2013-RN-01273-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01273-1
  • 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
    The manufacturer, brainlab ag has determined that pins of the instrument star unit ml (calibration with icm4) with specific serial numbers might have been made using an incorrect material that is not suitable for necessary disinfection and sterilisation of the product. consequently, the biocompatibility of these specific products cannot be ensured. pins made of this incorrect material will not withstand the necessary reprocessing procedures described in the brainlab cleaning, disinfection and sterilisation guide. the prescribed reprocessing procedures will cause visible corrosion of pins made of this incorrect material. one or multiple pins of each product might be affected. if this corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient’s body, potentially leading to infection and serious injury of the patient.
  • Action
    Customers are asked to identify the affected Instrument Star Units ML and remove them from clinical use. Brainlab Australia will arrange for affected stock to be recovered and replacement stock or a credit note to be issued.

Device

Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)
  • Model / Serial
    Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)Brainlab Article Number: 55830-25ASerial Numbers: 1205112016 and 1205112026ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd