Events

Recall of Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base

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-2016-RN-01409-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01409-1
  • 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
    Brainlab has identified that one part of the femoral and tibial cutting block adapter base was made from incorrect material. consequently, neither biocompatibility nor corrosion resistance of these specific products can be ensured. if corrosion of the femoral and tibial cutting block adapter base occurs and is not detected by the user, and the device is used during surgery, corroded particles could, directly or indirectly, enter the patient’s body and potentially cause tissue irritation or a cytotoxic reaction of the patient. corrosion may also impair successful reprocessing of this device part, so that residue from previous surgeries could adhere to the corroded material. if not detected by the user and the device is used during surgery, germs could be transferred to the patient and lead to infection of the patient. brainlab has not received any reports of such corroded products having been used in surgery, nor of any effects on patients, due to this issue.
  • Action
    Brainlab is advising users to identify all affected units and remove them from clinical use. They are also advised to dispose them and that they will be provided with a replacement stock. This action has been closed-out on 23/05/2017.

Device

Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base
  • Model / Serial
    Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter BaseProduct Number: 41888-04Serial Numbers: ranging from1267114001 to 1267114070 and 1308615032ARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd