Alerta De Seguridad para GUIDE TO TIBIAL DRILLING SIZE 5. Registration with Anvisa: 10178300054. Reference number of the product: 7144-0238. Affected lots: 08JM07761E 08JM07761A.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PCE 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
    1024
  • Fecha
    2010-06-15
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    The manufacturer of the product (Smith & Nephew Inc. - Orthopedic Division) began a worldwide recall of the product, due to the problem mentioned. According to the company, the use of the product can lead to unnecessary damage to the tibial bone.
  • Causa
    The markings on the tibial drill guide were made on the wrong side - the left side is printed on the right side and vice versa.
  • Acción
    Users should follow the instructions: (1) Verify in their inventory the existence of affected products; (2) If you identify an affected product in your stock, immediately stop the distribution and use of it, segregate it and identify it to avoid accidental use; (3) Communicate the registration holder (form attached to the Letter to Users, available at http://portal.anvisa.gov.br/wps/wcm/connect/b9fe7b0042e01d3f81ed814817069f5c/Formul%C3%A1rio_Recolhimento.pdf?MOD=AJPERES ).

Manufacturer

  • Source
    ANVSANVISA