Events

Recall of Osseotite® 2 Certain® PREVAIL® 5 X 4.1 X 11.5 mm, model number XIIOS5411, Osseotite® Paralle Walled Certain® 4 x 15 mm, model number IOSS415

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland that was produced by Biomet 3i.

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
    2013-1257
  • Date
    2013-07-16
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Extra notes in the data
    Source: NCAR
  • Reason
    Device failure / feature before use - manufacturing.

Device

Osseotite® 2 Certain® PREVAIL® 5 X 4.1 X 11.5 mm, model number XIIOS5411, Osseotite® Paralle Wall...

Manufacturer

Biomet 3i
  • 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
    VNSAWH