Events

Safety Alert for SAFETY SEALS. LOTS NOS.:5031 À 5341.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC MIDAS REX DIV MEDTRONIC 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
    56
  • Date
    2001-04-27
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    This safety seal may be inched during self-cleaning, which may cause seal shifting to incorrect motor connection mounting positions. the incorrect position may result in greater probabilities of oil leakage and deintegration of the seal during surgery. the manufacturer began a removal for a letter sent january 18, 2001.
  • Action
    VERIFY THAT YOU RECEIVED THE LETTER SENT JANUARY 18, 2001 FROM MEDTRONIC MIDAS REX. IDENTIFY AND ISOLE ALL PRODUCTS AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR MEDTRONIC REPRESENTATIVE OR MIDAS REX BY PHONE 0021-1-817-788-6400.

Device

SAFETY SEALS. LOTS NOS.:5031 À 5341.

Manufacturer

MEDTRONIC MIDAS REX DIV MEDTRONIC INC
  • Source
    ANVSANVISA