Events

Recall of Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)

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-2012-RN-01023-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01023-1
  • 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
    Synthes australia has identified an inconsistency found in the instructions for use supplied with the expert tibial nail protect. although no adversepatient events have been reported due to the identified issue, there is a potential that the use of the expert tibial nail protect in indications other than the ones in the technique guide of the expert tibial nail protect (036.000.380), may lead to improper application of this device and pose a health risk for patients.
  • Action
    Customers to return any product held. Sponsor will advise customers once revised Surgical Techniques and Indications for Use are available.

Device

Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate,...
  • Model / Serial
    Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)Part number: 04.004.XXXSABAll lot numbers are affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd