Events

Recall of Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling

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-00354-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00354-1
  • 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 product for this particular lot (3632704) was distributed with "not for human use" etched on the side of the tool. the etching was intended to indicate that the devices were for training purposes only. if the "not for human use" etching on the threaded reduction tool is discovered prior to its use on the patient, but in the operative theatre, it could lead to a small surgical delay until a replacement product is procured.Synthes has advised that if the product was used in an operation, the threaded reduction tool would work as intended and the patient would not be exposed to any increased risk.
  • Action
    End users are requested to immediately isolate any devices from the affected lot. Affected devices are to be returned to Synthes Australia.

Device

Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
  • Model / Serial
    Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal couplingPart Number: 03.507.002SLot Number: 3632704ARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd