Events

Recall of Navigational System II - Cart(Surgical navigation system)

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-2015-RN-00619-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00619-1
  • 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
    Between may 2012 and july 2014, ondal medical systems gmbh received three complaints from customers where a broken joint of the articulated arm was reported. for two of the complaints the parts failed directly after installation of the device, for the other complaint, the part failed after six months. the load attached to the arm was in all three cases was approximately 18 kg.Additional inspection is required because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
  • Action
    Stryker is requesting hospitals to check all stock areas and/or operating room storage and quarantine all affected equipment. A Stryker Representative will contact your facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera. This action has been closd-out on 15/08/2016.

Device

Navigational System II - Cart(Surgical navigation system)
  • Model / Serial
    Navigational System II - Cart(Surgical navigation system)Catalogue number: 7700-100-000Cart Serial Number: 100968, 100969Arm Serial Number: 11102258470, 11102258469ARTG Number: 127497
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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