Recall of DCP 2.0, 7 holes, length 37 mm, Stainless Steel, Sterile ( Non-biodegradable orthopaedic fixation plate)

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-2014-RN-00605-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-06-03
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    The label on the head text does not match the multilingual text ie, the number of holes is not correctly indicated in the multilingual text in the labelling for one or more of the languages.
  • Action
    Customers are advised to isolate the affected units and return it to Synthes Australia.

Device

  • Model / Serial
    DCP 2.0, 7 holes, length 37 mm, Stainless Steel, Sterile ( Non-biodegradable orthopaedic fixation plate)Part Number: 243.570SLot Number: 1864934ARTG Number: 157069
  • Manufacturer

Manufacturer