Events

Recall of Tibial Alignment Guide – iAssist Knee System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer 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-00482-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00482-1
  • 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
    Based upon complaint investigation, zimmer cas has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use. the bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilized. these stresses are significantly increased when the proper steps of the surgical technique are not followed. although unlikely, if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site. there have not been any complaints for this instrument associated with a spike being left in a patient. product manufactured after may 2014 is not affected as they have a different assembly method of the spike that reduces the risk of fatigue.
  • Action
    Zimmer is notifying hospitals and surgeons of this issuing and providing instructions on how to minimise the risk of bending or breaking. Further action will be carried out by Stryker pending the availability of replacement units. This action has been closed-out on 07/06/2016.

Device

Tibial Alignment Guide – iAssist Knee System
  • Model / Serial
    Tibial Alignment Guide – iAssist Knee SystemTibial Alignment Guide Part Number: 20-8011-013-00Lot Numbers: 120265, 120793, 120794, 130135, 130539ARTG Number: 205936
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA