Events

Safety Alert for TWINFIX ORTHOPEDIC SUCCESS ANCHOR - REGISTRY 10178300105 - Models 72200750/72200752/72200755/72200758 - Lots - See attached list .. http://portal.anvisa.gov.br/wps/wcm/connect/7ef36c804cf288afbe2ebe551355428f/Lotes+folded. pdf? MOD = AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PCE IMPORTAÇÃO, COMÉRCIO E MANUTENÇÃO DE MATERIAL CIRÚRGICO 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
    1187
  • Date
    2012-10-03
  • 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
    Anvisa follows this action. See Letter to the Client - http://portal.anvisa.gov.br/wps/wcm/connect/70b739004cf2883abe25be551355428f/Carta+aos+Clientesl.pdf?MOD=AJPERES.####ATUALIZAÇÃO - CLOSURE - file 0316135 / 13- 8 ####
  • Reason
    Compromising of the sterile barrier of the bag (packaging).
  • Action
    Suspension of use, identification of the affected product in the stock, segregation and communication to the supplier for collection. See Letter to the Client: http://portal.anvisa.gov.br/wps/wcm/connect/70b739004cf2883abe25be551355428f/Carta+aos+Clientesl.pdf?MOD=AJPERES.

Device

TWINFIX ORTHOPEDIC SUCCESS ANCHOR - REGISTRY 10178300105 - Models 72200750/72200752/72200755/7220...

Manufacturer

PCE IMPORTAÇÃO, COMÉRCIO E MANUTENÇÃO DE MATERIAL CIRÚRGICO LTDA