Events

Recall of Tension Band Pins (Internal fixation pins)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical & Optical Instruments 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-00449-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00449-1
  • 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
    Specific lots of tension band pins manufactured between july 2009 and march 2011 are being recalled because they were manufactured with astm f138 stainless steel but should have been manufactured with astm a276 stainless steel. both standards are grade 316l stainless steel and contain the exact same chemical elements but in different concentrations. although the biocompatibility was only tested on astm f138 there is no evidence to indicate that astm a276 is not biocompatible.
  • Action
    Medical + Optical is contacting their customers to arrange for the return of affected devices.

Device

Tension Band Pins (Internal fixation pins)
  • Model / Serial
    Tension Band Pins (Internal fixation pins)Part Numbers:TB-1550K-SLot Number: 223007TB-1570K-SLot Numbers: 220788, 230952 & 233742TB-1590K-SLot Numbers: 218700, 221465 & 223009ARTG Number: 99821
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd