Events

Recall of Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, cables and crimps/clamps)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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-2013-RN-00378-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00378-1
  • 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
    There have been reports of the instrument falling apart and/or the k-wire being trapped inside. the connection between the reaction fork and the main body is connected without a gap and secured with tightening of 23nm. there may be instruments which have not been tighten with adequate torque.
  • Action
    Synthes is requesting that customers return the affected devices for reworking by the manufacturer.

Device

Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, ca...
  • Model / Serial
    Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, cables and crimps/clamps)Part Number: 03.311.001Multiple lot numbers ARTG Number: 203636
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd