Events

Recall of Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-00934-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00934-1
  • 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
    Stryker has received product complaints stating that a rivet or rivets came off an exeter non v40 rasp handle. these complaints are associated with the exeter rasp handles with either the green or black plastic lever, manufactured between january 1995 and october 2005. the current exeter v40 rasp handles with a metallic lever are not within the scope of this recall. in the event that a rivet comes off the exeter non v40 rasp handle during surgery there are several hazards that would increase surgical time. these include locating the fragment, retrieving a sterilised replacement rasp handle and potentially an intra-operative x-ray if required. the exeter non v40 rasp handle may continue to function without the rivet.
  • Action
    Stryker is advising users to inspect inventory and quarantine and remaining units of the affected product for return. This action has been closed out on 15 June 2017.

Device

Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter fem...
  • Model / Serial
    Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)Product Code: 0930-9-003All lots manufactured between January 1995 and October 2005ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA