Events

Retiro De Equipo (Recall) de NOBELPROCERA ABUTMENT ZIRCONIA WHITE FOR STRAUMANN

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por NOBEL BIOCARE CANADA INC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71628
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-07-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Nobel biocare has become aware through a customer complaint that select abutments of nobelprocera abutment zr for straumann bone lvi nc 3.3 have been machined incorrectly. the abutment consists of a zirconia portion and an adapter portion that fits into the implant. the adapter portion was machined larger than specifications. the abutment will therefore not fit into the implant.

Device

NOBELPROCERA ABUTMENT ZIRCONIA WHITE FOR STRAUMANN
  • Modelo / Serial
    Model Catalog: 23451 (Lot serial: ALNH_168_10.C3B); Model Catalog: 70707 (Lot serial: AADU_1746_0010.C3B); Model Catalog: 24244 (Lot serial: AADU_1746_0010.C3B); Model Catalog: 70707 (Lot serial: YPW_1259_10.C3B); Model Catalog: 24244 (Lot serial: YPW_1259_10.C3B); Model Catalog: 24239 (Lot serial: ZHV_2218_10.C3B); Model Catalog: 24239 (Lot serial: XSL_2147_0010.C3B); Model Catalog: 70705 (Lot serial: ZHV_2218_10.C3B); Model Catalog: 70705 (Lot serial: XSL_2147_0010.C3B)
  • Descripción del producto
    NOBELPROCERA ABUTMENT ZR WHITE FOR STRAUMANN BONE LVI NC 3.3
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC