Events

Recall of Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-01315-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01315-1
  • 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
    Stryker has identified an issue with the tha 3.1 and tha 3.1.1 software which may cause the surgeon to experience a feeling of vibration in the robotic arm during acetabular preparation. should vibration occur, the surgeon may need to reposition the arm during reaming of a planned cup position which may result in complications associated with extended surgery time of less than 15 minutes. the occurrence of this vibration will be corrected through the installation of an upgraded software version tha 3.1.1.1 on the mako system.
  • Action
    Stryker is advising users to inspect inventory for affected products. Users with affected product will be contacted by Stryker who will coordinate the installation of a software update as a permanent correction. In the interim, users can continue to use the affected product and mitigate the risk of vibration by following the instructions on the User Guide (PN 210555 – THA 3.1 Application User Guide, PN 212026 – THA 3.1.1 Application User Guide) and Surgical Technique (PN 210558 – THA 3.1 Surgical Technique, PN 212027 – THA 3.1.1 Surgical Technique) for proper pin placement/ securement, recommended Mako system setup and patient securement. This action has been closed-out on 18/05/2017.

Device

Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigat...
  • Model / Serial
    Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)Item Numbers: 212212-01, 212212-03, 212212-99, 212212, 212103-01, 212103-03, 212103-99, 212103, 212110, 212100-01, 212100-03, 212100, 212220-01, 212220-03, 212220, 212042, 212034, 212239, 212240, 212243, 212244 (Kits that include software) ARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA