Events

Recall of DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length

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-00324-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00324-1
  • 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
    Synthes has two couplings in place for the dhs/dcs screws, standard with teethed recess and octagonal recess. the pictogram on the labels of the articles shows the wrong coupling. all other information on the label (e.G. coupling description in words) is correct.
  • Action
    Depuy Synthes is recalling the affected lots and is replacing them with unaffected units.

Device

DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagon...
  • Model / Serial
    DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable)DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various lengthPart number: 280.XXXSDHS/DCS Screw, Titanium Alloy (TAN), sterile, various lengthPart number: 480.XXXS Multiple lot numbers affected.ARTG number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd