Events

Safety Alert for prosthetic components for titanium implants - Implant Direct LLC

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Implant Direct Sybron Manufacturing, Llc.

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
    R1610-408
  • Event Number
    2008DM-0001545
  • Date
    2016-10-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • 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 it has detected the possibility of a problem with the design specifications (manufactured outside of specifications), this discrepancy can lead to the loosening of the screws and the patient would have to be intervened again, leading to potentially serious adverse events on the patients.

Device

prosthetic components for titanium implants - Implant Direct LLC
  • Model / Serial
    RePlant Angled Abutment / 6050-52-60, lots 50174, 39799 and 49364.
  • Product Description
    The pillars of the system provide supports for crowns, prostheses or dentures in patients totally or partially edentulous for cemented or screwed restorations.
  • Manufacturer
    Implant Direct Sybron Manufacturing, Llc

Manufacturer

Implant Direct Sybron Manufacturing, Llc