Events

Safety Alert for hydroxyapatite of bovine origin Endobon

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biomet 3I Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1601-33
  • Event Number
    2009DM-0004199
  • Date
    2016-01-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that in studies of cytotoxicity of the referenced product have shown a level 4 level for a study period of 36 months, however clarifies that for shorter periods (about 25 months approximately) the results have shown that there is no cytotoxicity, leading to potentially present adverse events on patients by exceeding the times determined as safe.

Device

hydroxyapatite of bovine origin Endobon
  • Model / Serial
    ROX05, ROX10, ROX20, ROXLG20, ROXLG50 and ROXLG80, with useful life time between January 2016 and September || 2018
  • Product Description
    To permanently reconstruct uninfected bone defects. Filling of defects by resection of osseous tumors or bone cysts, bone defects after apicoectomy, filling of periodontal pockets in the lower maxilla, filling of "fresh" alveoli after extractions, osteotomy of the jaws.
  • Manufacturer
    Biomet 3I Inc.

Manufacturer

Biomet 3I 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
    NIDFSINVIMA