Events

Retiro De Equipo (Recall) de GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical 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-2013-RN-00912-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-29
  • 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-2013-RN-00912-1
  • 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
    The manufacturer has advised that the tyvek lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. during a total knee arthroplasty surgery, the user will most likely notice the inadequate seal and request another device.
  • Acción
    Smith & Nephew is advising users to inspect products and quarantine affected devices. Affected devices will be replaced by Smith & Nephew.

Device

GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)
  • Modelo / Serial
    GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)GENESIS II PS Articular Insert Size 3-4 13mmCatalogue Number: 71420820Lot Number: 12GT20824GENESIS II PS High Flexion Insert Size 3-4 9mmCatalogue Number: 71421508Lot Number: 12GT20822ARTG Number: 114463
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd