Events

Safety Alert for STERILE FIXING SYSTEM FOR BIOPLATE NEUROCIRURGY. Anvisa Registry: 80145900964. Lots Affected in Brazil: 1000, 1075, G03211108, G03241108, G03251108, G03261108, G03431208, G03630409, G03660409, G03740509, G03820609, G03830609, G03920709.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson Medical Brasil.

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
    1021
  • Date
    2010-05-28
  • 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
    The Technovigilance Unit is following up on this case.
  • Reason
    Envelope seal width of some product packaging is out of specification, which may compromise product sterility.
  • Action
    Johnson & Johnson Ltda has already begun collecting affected lots. If you have the affected product in stock and have not yet been contacted by Johnson & Johnson or any of its distributors, please segregate the product (identify it correctly so that it is not inadvertently used) and contact the company. If a patient has recently received the implantable article (under risk), it should be monitored.

Device

STERILE FIXING SYSTEM FOR BIOPLATE NEUROCIRURGY. Anvisa Registry: 80145900964. Lots Affected in B...

Manufacturer

Johnson & Johnson Medical Brasil