Events

Recall of Low Profile Abutment Hexed Castable Cylinder, Model LPCCC1

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-2012-RN-00722-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00722-3
  • 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
    Biomet 3i has become aware that some packages labelled lpccc1, hexed castable cylinder, may contain lpccc2 non-hexed castable cylinder. according to biomet 3i, this condition will not have any effect on patient health. however, difficulty may be encountered in the lab durung use due to the ease of rotation of the non hexed cylinder.This recall action was not notified to the tga before it was initiated by biomet 3i australia pty ltd.
  • Action
    The sponsor is asking users to return affected stock for a replacement.

Device

Low Profile Abutment Hexed Castable Cylinder, Model LPCCC1
  • Model / Serial
    Low Profile Abutment Hexed Castable Cylinder, Model LPCCC1Lot no's:2010100001, 2010080684, 2010090191
  • 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