Events

Recall of Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire

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-00819-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00819-1
  • 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
    The design verification for the previous packaging configuration does not cover the 70cm wires. whilst there has not been any complaints involving a breach in sterility, zimmer has completed a design verification to move the 70cm guide wires to a new packaging configuration. as a result, the products packaged in the previous packaging configuration are being retrieved from the market.
  • Action
    Zimmer is requesting that Customers: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Assist your Zimmer Biomet sales representative by quarantining all affected product; 3. A Zimmer Biomet sales representative will remove the affected product from your facility; 4. Complete the Certificate of Acknowledgement as supplied by Zimmer; 4.a Return a digital copy to RAQA.ANZ@zimmerbiomet.com; and 4.b Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.

Device

Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire
  • Model / Serial
    Trauma Guide Wires, 70cmBall Tip Guide Wire 2.4mmItem Number: 47-2255-008-003mm x 70cm Tear Drop Guide WireItem Number: 47-2490-098-00Expiry Date: April 2022ARTG Number: 118540
  • 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