Events

Recall of Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system

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-01319-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01319-1
  • 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 expiration date on the label is incorrect. the affected sterile product components (comprising of a locking clip and a drive shaft seal packaged as separate parts) were labelled with expiration dates of 10 years rather than 2 years from the date of manufacturer.
  • Action
    Synthes is advising their customers to check inventory and to quarantine and return any affected units. This action has been closed-out on 07/07/2016.

Device

Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system
  • Model / Serial
    Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system Part Numbers: 352.260S and 351.718.02S Multiple lot numbers affected ARTG Number:157016
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd