Events

Recall of Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomet 3i 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-2018-RN-00509-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00509-1
  • 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 a single lot of tapered screw-vent implants that were inadvertently packaged with patient chart labels which incorrectly indicate tsvb10 lot number 63773888. all outer and inner labels are correct.
  • Action
    For unused product, Zimmer Biomet is advising customers to return affected product. For implanted devices, Zimmer is advising customers to update patient records with the correct part and lot number.

Device

Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves
  • Model / Serial
    Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and MicrogroovesPart Number: TSVM4B10Lot Number: 63781164ARTG Number: 126088
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia 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