Events

Recall of Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)

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-01137-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01137-1
  • 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 orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant. upon investigation, it was determined that the press fit between the threaded stud and the handle shaft assembly for the trident universal impactor/positioner may lead to the gradual protrusion of the threaded stud over time. this may result in a delay in surgery, fracture or pain associated with the implant loosening.
  • Action
    Stryker is advising users to inspect inventory and quarantine affected product for return. This action has been closed out on 16 June 2017.

Device

Universal Impactor/Positioner (used to introduce and extract compatible universal window trials a...
  • Model / Serial
    Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)Item Number: 2101-0200Multiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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