Events

Safety Alert for Navigation System II-Cart and Articulated Arm Camera

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Stryker Instruments and Stryker Leibinger GmbH & Co. KG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-05-19
  • Event Date Posted
    2015-05-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150519.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: stryker navigation system ii-cart and articulated arm camera medical device manufacturer, stryker instruments and stryker leibinger gmbh & co. kg, has issued a field safety notice concerning navigation system ii-cart and articulated arm camera, with the following details: navigation system ii-cart: product code 7700-100-000 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera: product code 7700-103-001 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera (refurbished): product code 7700-103-001u distributed from 23 dec 2011 to 3 aug 2012 according to the manufacturer, 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 failure of the arm joint. a failure in the weld joint could result in interruption or discontinued use of the navigation system. the manufacturer will perform inspection to all affected systems. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2015.

Device

Navigation System II-Cart and Articulated Arm Camera

Manufacturer

Stryker Instruments and Stryker Leibinger GmbH & Co. KG
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH