Events

Recall of Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)

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-2015-RN-00972-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00972-1
  • 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 a customer complaint which reported that during a total hip replacement the surgeon was using the exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip. this may result in the tip of the reamer detaching from the instrument. should this occur and the fragment remain in situ, there are additional potential hazards including excessive metal ions and displacement from mri.
  • Action
    Stryker is advising users to quarantine any affected stock for replacement.

Device

Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)
  • Model / Serial
    Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)Catalogue Numbers: 0932-0-000 (small) and 0932-2-000 (large)Lot Numbers (small): GW281208, GW284192, GW288907, GW282586, GW282310, GW298838, GX303720, GX302994 and GX301732 Lot Numbers (large): GW288908, GW282454 and GW288485ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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