Events

Alerta De Seguridad para 80371250003 - Ductable Intervertebral Stabilization Plate in Peek ;. 80371250004 - Screw Masterteck Peek LT1

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bioteck Indústria, Comércio, Importação e Exportação de Implantes Bio-absorviveis LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1014
  • Fecha
    2010-03-31
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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