Events

Recall of Affixus Hip Fracture Nail

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Biomet 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-2017-RN-00559-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00559-1
  • 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
    Zimmer biomet has identified an issue with the affixus hip fracture nail not properly engaging with the targeting jig. an investigation into the nail/targeting jig assembly showed that certain specifications were undersized causing interference to the fit of the nail onto the targeting jig which can result in a surgical delay.
  • Action
    Users are asked to:- 1. Review the notification and ensure affected personnel are aware of the contents; 2. Quarantine all affected product for collection by your Zimmer Biomet sales representative; 3. Complete and return the acknowledgement form as per the instructions in the customer letter; and 4. Notify Zimmer Biomet of any adverse events associated with this device.

Device

Affixus Hip Fracture Nail
  • Model / Serial
    Affixus Hip Fracture NailMultiple Item NumbersARTG Number: 212235
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet 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