Events

Recall of AVS ARIA Implant Inserter

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-2014-RN-00733-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00733-1
  • 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 reports of fracture of the vertebral peek spacers when implanted with the avs aria implant inserter. according to the reported complaints, the proximal end of the implant either cracks or the tip breaks off in one fragment. there have been no reports of the broken fragment remaining in the surgical site.
  • Action
    Stryker is advising their customers to quarantine any affected lots and will arrange for the return of any affected lots from the field.

Device

AVS ARIA Implant Inserter
  • Model / Serial
    AVS ARIA Implant InserterItem number: 48758500 (Located in Instrument Tray 48759040-T)Lots numbers affected: 107400, 10G906, 110214ARTG number: 178870
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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