Events

Recall of Power-LOAD (Cot Fastener)

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-2018-RN-00296-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00296-1
  • 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
    After installation of the power-load, the floor plate attachment brackets (pn: 6390-101-108) which allow the power-load anchor to be secured to the power-load floor plate may be found to be broken after removing the anchor. the manufacturer has advised that broken floor plate attachment brackets will not result in unintended movement of the cot under normal conditions. the holding strength of the cot is reduced as a result of this issue which may result in a detached cot with fastener or a detached fastener component in the event of an emergency service vehicle accident. to date, there have been no reported injuries as a result of this issue.
  • Action
    Stryker is advising that they will be replacing potentially affected parts on all Power-LOAD units manufactured within the suspected time frame. A Stryker Technician will contact users upon receipt of the Notification Response Form provided with the Customer Letter (issued to affected users) to co-ordinate the correction.

Device

Power-LOAD (Cot Fastener)
  • Model / Serial
    Power-LOAD (Cot Fastener)Item Numbers: 6390000000, 6390BASIC, 6390SSPAUnits manufactured between Jan 1 2016 to Dec 31 2016All serial numbers beginning with “16” are within scope of this action ARTG Number: 275902
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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