Events

Safety Alert for Fixing System for Large and Small Fragment Plates in Impol Steel, Model Umero Proximal Locking Plate 3 holes, Registration No. 10108770117, lot: 0504/0913

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Impol Instrumental e Implantes Ltda..

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
    1620
  • Date
    2015-07-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    According to the manifestation of the company, the conformation in the act of manufacture does not alter the structure of the raw material due to the little deformation presented in the geometry of the prosthesis.
  • Reason
    Identified use of steel in disagreement with that specified in technical standard.
  • Action
    The manufacturing company informs that it has already collected the units not implanted and that it sent a letter to the health services to obtain information on the clinical conditions of the patients.

Device

Fixing System for Large and Small Fragment Plates in Impol Steel, Model Umero Proximal Locking Pl...

Manufacturer

Impol Instrumental e Implantes Ltda.