Events

Recall of Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T

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-00217-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00217-1
  • 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
    During continuous monitoring and analysis of trumpf medical products installed in the field, some customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. investigations indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. the product has not been involved with any reported injuries.
  • Action
    Trumpf Medical is advising users to confirm all mechanical functions are parts are undamaged and in good working order prior to each use as outlined in the IFU. In cases where it is identified that the device is defective, damaged, leaking oil or will not hold its set position, stop use of the device and contact Trumpf Medical: service.au@trumpfmedical.com to receive the replacement parts. Please ensure replaced part sare returned to Trumpf Medical.

Device

Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T
  • Model / Serial
    Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U TModel Numbers: 1697630, 1697635, 1697639, 1697651, 1697660, & 1697662.Serial Numbers up to (respectively): 103106579, 103011318, 102631713, 102968819, 102956866, 102945650Manufactured between May 2012 and Aug 25 2016ARTG Number: 296295Trumpf Med Aust - Holder, patient, arm
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd