Events

Field Safety Notices about Zimmer® segmental system of polyethylene cartridge-size B & size C

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by Zimmer, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    2014_zimmer_segmental_system_polyethylene_insert_size_b_and_size_c_1006
  • Date
    2014-01-17
  • Event Country
    Croatia
  • Event Source
    AMPMDC
  • Event Source URL
    http://www.halmed.hr/en/Medicinski-proizvodi/Sigurnosne-informacije/Sigurnosne-obavijesti-o-medicinskim-proizvodima/2014/Zimmer-segmental-system-polyethylene-insert-size-B-and-size-C/1006
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, Inc., SAD on the changes in instructions for use and applicable surgical technique due to complaint reports to hyperextension of polyethylene inserts.
    Here you may view the safety information addressed to users.

Device

Zimmer® segmental system of polyethylene cartridge-size B & size C

Manufacturer

Zimmer, Inc.
  • 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
    AMPMDC