Events

Recall of Brainlab Offset Cup Impactor Universal (blue handle)

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-2017-RN-00178-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00178-1
  • 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
    An issue has been detected that when the brainlab offset cup impactor universal (blue handle) is reprocessed in a sterilisation tray as described in the current brainlab cleaning, disinfection and sterilisation guide (revision 5.2 and previous versions), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 can only be achieved if the device is individually wrapped for sterilisation. if a non-sterile brainlab offset cup impactor universal (blue handle) is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to an infection. at this stage, there have been no reports of affected patients due to this issue.
  • Action
    Brainlab is advising users to follow the sterilisation instructions in the current version (BL-IL-60960-69ML Rev. 1) of the IFU. Users are reminded that in addition to following the other instructions in the IFU, the Offset Cup Impactor Universal (blue handle) must be sterilized in an individually wrapped configuration.

Device

Brainlab Offset Cup Impactor Universal (blue handle)
  • Model / Serial
    Brainlab Offset Cup Impactor Universal (blue handle)Catalogue Numbers: 52856, 52856AARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd