Events

Alerta De Seguridad para Adapters, Handpieces, ITI Dental Implant System with Instruments: (1) Extra Short, (2) Short. Catalog No.: (1) 046,470, (2) 046,471; Lot No: 1200

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por The Streumann Co; Institut Straumann AG.

¿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
    392
  • Fecha
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The handpiece adapter of the dental instrument above may fail or snap, sometimes requiring high rotation. the dealer initiated a correction by letter dated december 7, 2001.
  • Acción
    Make sure you have received from Straumann USA the letter dated December 7, 2001, return package and Federal Express prepaid airfare. Identify and isolate any affected product in your inventory. Return the affected product to Straumann USA using Federal Express prepaid airfare and return package. Srtaumann USA will replace the affected product immediately upon receipt. For more information, contact your local Straumann representative. . For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Adapters, Handpieces, ITI Dental Implant System with Instruments: (1) Extra Short, (2) Short. Cat...

Manufacturer

The Streumann Co; Institut Straumann AG