Events

Retiro De Equipo (Recall) de T2 ARTHRODESIS NAIL LEFT STERILE

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

¿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
    49557
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-17
  • 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
    Strykerr trauma has become aware of the potential for the sterility of above noted t2 knee nails to become compromised following high volume transport. in all cases the protection cap came off the nail and the nail had punctured the pouches which led to loss of sterility of the nail.

Device

T2 ARTHRODESIS NAIL LEFT STERILE
  • Modelo / Serial
    Model Catalog: CONTACT MANUFACTURER (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1124S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1104S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1112S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1108S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1116S (Lot serial: CONTACT MANUFACTURER); Model Catalog: CONTACT MANUFACTURER (Lot serial: ); Model Catalog: 1829-1170S (Lot serial: ); Model Catalog: 1829-1154S (Lot serial: ); Model Catalog: 1829-1162S (Lot serial: ); Model Catalog: 1829-1158S (Lot serial: ); Model Catalog: 1829-1166S (Lot serial: )
  • Descripción del producto
    t3 ARTHRODESIS NAIL LEFT STERILE
  • Manufacturer
    STRYKER TRAUMA GMBH

Manufacturer

STRYKER TRAUMA GMBH
  • Dirección del fabricante
    SCHOENKIRCHEN
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC