Events

Recall of Apex 10mm reamer

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Orthopaedic Technology 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-2015-RN-00419-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00419-1
  • 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
    Sequential reaming of the patient's femur was being carried out during a total hip replacement(thr) procedure. following the use of the 8mm reamer, the 10mm reamer was introduced. during reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. a distal window was cut into the femur, and the broken section of the reamer removed. under torque the reamer broke at a weld joint. the joint was insufficiently strong.This action is undertaken prior to notifying the tga.
  • Action
    Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers.

Device

Apex 10mm reamer
  • Model / Serial
    Apex 10mm reamer ARTG Number: 183711CER-227: 16-May-2011- 8.5mm REAMER Lot L0805CER-257: 10-Aug-2011 - 16mm REAMER Lot L0805CER-358: 18-0ct -2012 - 10mm REAMER Lot L0805
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd