Events

Recall of Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial 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-00591-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00591-1
  • 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
    The affected part and lots numbers of the "orbital rim plate" have been mislabelled as "orbital floor plate". the mislabelling non-conformance may result in user dissatisfaction, but is not likely to impact the patient.
  • Action
    DePuy Synthes is notifying their customers of the correct label information for the Orbital Rim Plate and Orbital Floor Plate.

Device

Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial fixation plate)
  • Model / Serial
    Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial fixation plate)Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium Part Number: 421.021Multiple lot numbers affected Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium, sterile Part Number: 421.021SMultiple lot numbers affectedARTG Number: 157706
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd