Events

Retiro De Equipo (Recall) de TNCIGFT3 XTS #3 GOLDSTE IN FLEXI-THIN COMPOSITE INSTRUMENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS 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
    89403
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-06-03
  • 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
    The company recorded a higher rate of returns for this product for breakage compared to the historic average. the company analyzed the mode of failure and identified an opportunity to improve the manufacturing process for this item. the company wishes to replace product in the field to lessen the chance of customer dissatisfaction.

Device

TNCIGFT3 XTS #3 GOLDSTE IN FLEXI-THIN COMPOSITE INSTRUMENT
  • Modelo / Serial
    Model Catalog: TNCIGFT3 XTS (Lot serial: >10 Lots contact MFG); Model Catalog: TNCIGFT3 XTS (Lot serial: > 10 lots contact manufacturer); Model Catalog: TNCIGFT3 XTS (Lot serial: > 10 lot contact manufacturer); Model Catalog: TNCIGFT3 XTS (Lot serial: > 10 Lots contact MFG); Model Catalog: CIGFT38 (Lot serial: >10 lots contact mfg); Model Catalog: CIGFT36 (Lot serial: >10 lots contact mfg); Model Catalog: CIGFT36 (Lot serial: > 10 Lots of mfg); Model Catalog: CIGFT36 (Lot serial: > 10 lots contact MFG); Model Catalog: CIGFT38 (Lot serial: > 10 lots contact mfg); Model Catalog: CIGFT3 (Lot serial: > 10 lots contact mfg); Model Catalog: CIGFT3 (Lot serial: > 10 lot contact manufacturer)
  • Descripción del producto
    #3 Goldstein Flexi-Thin Composite Instrument
  • Manufacturer
    BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS INC.

Manufacturer

BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Henry Schein Inc
  • Source
    HC