Events

Safety Alert for Implant System and Dental Components

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials.

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
    R1710-515
  • Event Number
    2015DM-0003183-R1
  • Date
    2017-10-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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 has detected that the device may contain a manufacturing condition that affects the geometry of the driver's hexagonal characteristic, which prevents the components from being properly assembled, leading to possible delays in procedures and adverse events on the patients.

Device

Implant System and Dental Components
  • Model / Serial
    GEMLOCK 2.5mm RHD2.5, TSVKIT, specific lots
  • Product Description
    Dental ZIMMER implant systems are designed for use in the maxilla or mandible for immediate loading or loading after the conventional healing period has elapsed. These implants can be used to replace the absence of one or more teeth. Immediate loading is indicated when there is good primary stability and adequate occlusal loading
  • Manufacturer
    Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials

Manufacturer

Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials
  • 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