Events

Recall of Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)

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-01191-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01191-1
  • 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 become aware that there is a remote likelihood that the lock washer and screw which secure the monitor onto the shape arm are not present. if the shape arm lock washer and screw are not present the monitor could separate and dislodge from the arm potentially resulting in injury. given the scope of the recall, there is a remote likelihood for this situation to occur.
  • Action
    Stryker is inspecting all affected Shape Arms to determine if the lock washer and screw are missing. If missing a new lock washer and screw will be fitted. This action has been closed-out on 29/08/2016.

Device

Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
  • Model / Serial
    Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)Shape Arm Kit LeftCatalogue Number: 0682000976 Serial Numbers: 080924DC001 through 120227DC025Shape Arm Kit RightCatalogue Number: 0682000977 Serial Numbers: 080909DB001 through 131021DB013ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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