Retiro De Equipo (Recall) de MEDPOR BARRIER IMPLANT

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

¿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
    94010
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-29
  • País del evento
  • 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
    Stryker has become aware that there is a higher occurrence rate of implant damaged during intra-operative handling. a higher occurrence rate of implants breakage intra-operatively may be experienced. for the barrier sheets a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. stryker has become aware that the barrier location is on incorrect side of implant for part number 81036. the barrier is incorrectly situated on the inferior (bottom) surface of the implant instead of the superior (top) surface when the implant is properly oriented in the patient's right orbit.

Device

  • Modelo / Serial
    Model Catalog: 9312 (Lot serial: A1402023); Model Catalog: 9305 (Lot serial: A1402023); Model Catalog: 9312 (Lot serial: A1312011); Model Catalog: 9305 (Lot serial: A1312011); Model Catalog: 9312 (Lot serial: A1311044); Model Catalog: 9305 (Lot serial: A1311044); Model Catalog: 9312 (Lot serial: A1311008); Model Catalog: 81036 (Lot serial: A1402020); Model Catalog: 9312 (Lot serial: A1310051); Model Catalog: 9305 (Lot serial: A1310051); Model Catalog: 9312 (Lot serial: 81799); Model Catalog: 9305 (Lot serial: 81799); Model Catalog: 9312 (Lot serial: 77004); Model Catalog: 9305 (Lot serial: 77004); Model Catalog: 9312 (Lot serial: 69698); Model Catalog: 9305 (Lot serial: 69698); Model Catalog: 86001 (Lot serial: A1404026); Model Catalog: 86001 (Lot serial: A1405048); Model Catalog: 81036 (Lot serial: A1405060); Model Catalog: 9305 (Lot serial: A1404010); Model Catalog: 9312 (Lot serial: A1404010); Model Catalog: 9305 (Lot serial: A1403008); Model Catalog: 9312 (Lot serial: A1403008); Model Catalog: 9305 (Lot
  • Descripción del producto
    MEDPOR BARRIER IMPLANT
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
  • Source
    HC