Events

Safety Alert for Articular Prosthesis and its Associated Instrument

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

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
    I1804-239
  • Event Number
    2009DM-0003101
  • Date
    2018-04-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • 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

Device

Articular Prosthesis and its Associated Instrument
  • Model / Serial
    Epoca revision set and its stem extractors
  • Product Description
    EPOCA is a modular system of joint prostheses and associated instrumental specific and indispensable for the placement of such prostheses destined for the total, partial replacement or reconstruction of shoulder articulation and is indicated for: advanced destruction resulting from rheumatoid or post-traumatic or degenerative arthritis of the shoulder joint ; avascular necrosis; fractures in the shoulder joint; failure of previous surgery such as osteosynthesis, reconstruction of the joint or arthroplasty of the shoulder joint; reconstruction of the humeral portion of the shoulder joint by severe damage and / or disabled by rheumatoid arthritis, traumatic or necrosisavascular arthritis where radiographic evidence of sufficient bone tissue to support the prosthesis is found.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh