Events

Retiro De Equipo (Recall) de EMAX SAGITTAL SAW - MOTOR

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

¿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
    55119
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-30
  • 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
    Synthes (canada) was advised that anspach identified through internal sterility assurance level (sal)validation testing that several attachments failed to meet 10-6 sal when sterilized by the sterrad 100s sterilization method that is specified in the current directions for use (dfu) and operating manuals provided with the device.

Device

EMAX SAGITTAL SAW - MOTOR
  • Modelo / Serial
    Model Catalog: MM-SAGITTAL (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: DRIVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: S-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: SHORT (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: MEDIUM (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: LONG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: O-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: B-SILVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: ADG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-N (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-O (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A-R (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: EMAX2-HC (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-L (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRAN
  • Descripción del producto
    EMAX SAGITTAL SAW - MOTOR
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC