Events

Safety Alert for (1) ROD FOR HANGING TRANSMITTED DTT 100MM, Anvisa record 10208610026, lot 050231; and (2) ROD of 6.35x400MM, Anvisa record 10208610042, lot A53167-0.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ENGIMPLAN ENGENHARIA DE IMPLANTE INDÚSTRIA E COMÉRCIO 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
    1069
  • Date
    2011-07-19
  • 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
    During sanitary inspection carried out at the company Engimplan Engenharia de Implantes Indústria e Comércio Ltda, samples of the products mentioned in this alert were collected. Such gems were submitted to tests at the Physical Metallurgy Laboratory - LAMEF with the objective of verifying the quality of the products. According to the results, the HASTE FOR HOOK DTT TRANSVERSA 100MM, lot 050231, has raw material different from that declared to Anvisa in the product registration process and HASTE Ø 6,35 X 400MM, lot A53167-0, has detected faults on the surface of the product, which compromises the use of the product. In view of these results, Anvisa ordered the suspension of the distribution, trade and implantation, throughout the national territory, of said implants.
  • Reason
    Suspension of distribution, trade and implantation, throughout the national territory, of the aforementioned products, as a result of the use of raw material in disagreement with what appears in the product registration process (in the case of the haste para gancho ddt transversa product) and faults on the surface of the product (in the case of product rod of 6.35x400mm).
  • Action
    If they have products at risk (lots listed in this alert) in their material stocks, health facilities should properly identify and segregate the prosthesis (s) in order to avoid the use of the same (s).

Device

(1) ROD FOR HANGING TRANSMITTED DTT 100MM, Anvisa record 10208610026, lot 050231; and (2) ROD of ...

Manufacturer

ENGIMPLAN ENGENHARIA DE IMPLANTE INDÚSTRIA E COMÉRCIO LTDA.
  • Source
    ANVSANVISA