Events

Recall of Extraction Screw for PFNA Blade

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-2016-RN-00026-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00026-1
  • 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 lots of the extraction screw could break or disassemble from the instrument. this may interfere with removal of the pfna and pfna-ii blade from the patient.The reported issue could lead to surgical delay and/or adverse tissue reaction.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Extraction Screw for PFNA Blade

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes