Events

Retiro De Equipo (Recall) de HINTEGRA REVISION TALAR COMPONENT

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

¿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
    70423
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-02-26
  • 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
    Newdeal sas a company within integra lifesciences group has recently identified through an internal evaluation a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch thus posing the risk of a potential patient infection.

Device

HINTEGRA REVISION TALAR COMPONENT
  • Modelo / Serial
    Model Catalog: 301 121 (Lot serial: ALL LOTS); Model Catalog: 301 200 (Lot serial: ALL LOTS); Model Catalog: 301 202 (Lot serial: ALL LOTS); Model Catalog: 301 203 (Lot serial: ALL LOTS); Model Catalog: 302 125 (Lot serial: ALL LOTS); Model Catalog: 302 124 (Lot serial: ALL LOTS); Model Catalog: 302 123 (Lot serial: ALL LOTS); Model Catalog: 302 122 (Lot serial: ALL LOTS); Model Catalog: 302 121 (Lot serial: ALL LOTS); Model Catalog: 301 125 (Lot serial: ALL LOTS); Model Catalog: 301 124 (Lot serial: ALL LOTS); Model Catalog: 301 123 (Lot serial: ALL LOTS); Model Catalog: 301 122 (Lot serial: ALL LOTS); Model Catalog: 301 201 (Lot serial: ALL LOTS); Model Catalog: 302 206 (Lot serial: ALL LOTS); Model Catalog: 302 205 (Lot serial: ALL LOTS); Model Catalog: 302 204 (Lot serial: ALL LOTS); Model Catalog: 302 203 (Lot serial: ALL LOTS); Model Catalog: 302 202 (Lot serial: ALL LOTS); Model Catalog: 302 201 (Lot serial: ALL LOTS); Model Catalog: 302 200 (Lot serial: ALL LOTS); Model Catalog: 301 206 (Lot serial:
  • Descripción del producto
    HINTEGRA REVISION TALAR COMPONENT
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.