Events

Recall of Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Trumpf Med Aust 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-00316-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00316-1
  • 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
    Allen medical has become aware that the rail section clamps used to attach the leg support of the t3 trumpf table may fail during use, which could result in critical harm to the patient. the t3 trumpf table top rail section clamps, f-t3railsc, are designed and labelled for use with armboards only but were shipped to be used with the leg support. the instructions for use (d-720595-a3) incorrectly guides the user to connect the top rail section clamp to the leg support.Three complaints without any allegation of injury have been reported since introduction in september 2009.
  • Action
    Trumpf are advising users to ensure that the T3 Trumpf Table Top Rail Section Clamps are used with armboards only. Users should inspect beds and remove any clamps currently in use with the Leg support. Allen Medical will be providing users with new Rail Section Clamps along with revised Instructions for Use. These are expected to be available by May 2018.

Device

Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016
  • Model / Serial
    Trumpf Table Top Spinal System (T3SYSTEM)Manufacturing Dates: March 2009 to November 2016ARTG Number: 252619(Trumpf Med Aust - Table, operation)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd