Events

Safety Alert for 80371250003 - Ductable Intervertebral Stabilization Plate in Peek ;. 80371250004 - Screw Masterteck Peek LT1

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bioteck Indústria, Comércio, Importação e Exportação de Implantes Bio-absorviveis 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
    1014
  • Date
    2010-03-31
  • 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 registry holder, a letter was sent to its distributors informing them of the suspension of distribution, trade and use. #### Update: On 08/28/2010, registration no. 80371250003 of the product "Divided Peak Intervertebral Stabilizer Plate" was canceled by Anvisa. #### Update: 10/19/2011 - The company forwards the electronic document with the measures implemented and in progress stated in the Action Plan, for the collection and destruction of all affected products.
  • Reason
    Suspension of distribution, commerce and use, throughout the national territory, of the products:. ductile intervertebral stabilizing plate in peek and (2). masterteck peek lt1 screw, manufactured by bioteck ind. with. imp. exp. de implantes bio-absorvíveis ltda., due to non-compliance with good manufacturing practices (gmp) requirements. resolution re 606 - official journal of the union (dou) nº 33, february 19, 2010 - section 1 - issn 1677-7042 - page 26.
  • Action
    In the process of investigation, according to routine UTVIG / NUVIG / ANVISA.

Device

80371250003 - Ductable Intervertebral Stabilization Plate in Peek ;. 80371250004 - Screw Masterte...

Manufacturer

Bioteck Indústria, Comércio, Importação e Exportação de Implantes Bio-absorviveis LTDA