Events

Field Safety Notices about OPTIPAC BONE CEMENT

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by BIOMET Orthopaedics Switzerland GmbH.

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
    867
  • Date
    2016-11-29
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

OPTIPAC BONE CEMENT
  • Model / Serial
    Catalog Number: Optipac Hipset; Optipac 40 Refobacin Bone Cement R ;Optipac 60 Refobacin Bone Cement R; Optipac 80 Refobacin Bone Cement R; Optipac Softpac Hipset; Optipac-S 40 Refobacin Bone Cement R; Optipac-S 60 Refobacin Bone Cement R; Optipac-S 80 Refobacin Bone Cement R; Optipac Knee Refobacin Bone Cement R; Optipac 40 Refobacin Plus Bone Cement; Optipac 60 Refobacin Plus Bone Cement; Optipac 80 Refobacin Plus Bone Cement; Optipac-S Knee Refobacin Bone Cement R; Optipac Softpac Refobacin Revision 40; Optipac-S 60 Refobacin Plus Bone Cement; Optipac-S 80 Refobacin Plus Bone Cement; Optipac Knee Refobacin Plus Bone Cement; Optipac Refobacin Revision 40; Optipac Refobacin Revision 80; Optipac-S Knee Refobacin Plus Bone Cement; Optipac-S Refobacin Revision 80, Optipac S 40 Refobacin Plus Bone Cement. Batch Number: Viz FSN
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    BIOMET Orthopaedics Switzerland GmbH

Manufacturer

BIOMET Orthopaedics Switzerland GmbH
  • 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
    MHSIDCCCDMIS