Events

Alerta De Seguridad para #Product: Masterteck Peek LT1 Screw. #Registration: 80371250004.. #Models: PMASPK001 - 7x24mm, PMASPK002 - 7x30mm, PMASPK003 - 8x24mm, PMASPK004 - 8x30mm, PMASPK005 - 9x24mm, PMASPK006 - 9x30mm, PMASPK007 - 10x24mm, PMASPK008 - 10x30mm. . # PMASPK001-Masterteck Screw - 7x24mm - Batch PMAS190 ;. # PMASPK002-Masterteck Screw - 7x30mm - Batch PMAS196 ;. # PMASPK003-Masterteck Screw - 8x24mm - Batch PMAS195 ;. # PMASPK004-Screw Masterteck - 8x30mm - Lot PMAS194 ;. # PMASPK005-Masterteck Screw - 9x24mm - Batch PMAS193 ;. # PMASPK006-Masterteck Screw - 9x30mm - Batch PMAS192 ;. # PMASPK007-Masterteck Screw - 10x24mm - Batch PMAS189 ;. # PMASPK008-Screw Masterteck - 10x30mm - Lot PMAS191 ;. # PMASPK009-Masterteck Screw - 11x24mm - Batch PMAS197 ;. # PMASPK010-Masterteck Screw - 11x30mm - Pack PMAS198.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis 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
    1217
  • Fecha
    2012-11-29
  • 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 company's assessment, there is no risk to the health of customers / patients associated with the use of the affected product. ANVISA and VISA RS are following the Field Action.
  • Causa
    Discrepancy was detected in the date of manufacture and the validity of the masterteck peek lt1 screw in relation to the format defined in the product registration process. the divergence detected is the dates printed on the labels of the products in year / month / day format, and in the product registration was defined by the format day / month / year. according to the evaluation of the company has occurred error, it is not about falsification of the product and there is no risk associated with the product and / or its validity.
  • Acción
    Date format correction on product labeling.

Device

#Product: Masterteck Peek LT1 Screw. #Registration: 80371250004.. #Models: PMASPK001 - 7x24mm, PM...

Manufacturer

Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis Ltda.
  • Source
    ANVSANVISA