Events

Retiro De Equipo (Recall) de METS Principal Shaft

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty 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
    RC-2017-RN-01412-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01412-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Stryker has initiated a lot specific hazard alert. the mets product family of components are double pouched in polyamide/polyethylene (pa/pe) material and a box. during inspection, certain mets principal shafts were found to be missing the outer pouch. upon review, two additional principal shafts from the same lot were also discovered to be missing an outer pouch.
  • Acción
    Patients implanted with an affected lot number of the METS Principal Shaft should continue to be followed per the normal protocol established by his/her surgeon. Inform users of this Hazard Alert and forward this notice to all those individuals who need to be aware within your organisation. Complete the “Hazard Alert Notification Response” form, and return the form to Stryker electronically by email as directed.

Device

METS Principal Shaft
  • Modelo / Serial
    METS Principal ShaftItem Number - msfshaft/150Lot Number - B10562ARTG Number: 246516 (Stryker Australia Pty Ltd - Femur/tibia shaft prosthesis)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA