Events

Retiro De Equipo (Recall) de PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)

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-2015-RN-00922-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-01
  • 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-2015-RN-00922-1
  • 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 received four customer complaints for lfit v40 vitallium femoral heads (manufactured july 7th 2014 – august 15th 2014) reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion at the time of surgery. upon investigation it was found that the female v40 taper of the four complaint devices were not machined per drawing specifications, leaving a lip protruding from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully locking with the associated male stem trunnion. in each case a new v40 lfit vitallium femoral head was opened and used. no other adverse consequences or delays to surgery were reported for any of these complaints.
  • Acción
    Stryker is advising users to inspect stock and quarantine any affected devices. Stryker will replace any affected devices with unaffected devices. A femoral head that has not achieved a taper lock will be clearly evident during verification, thus reducing the occurrence of the implantation of an unlocked femoral head.

Device

PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)
  • Modelo / Serial
    PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)Multiple catalogue numbers affectedMultiple lot numbers affectedARTG Numbers: 211858, 211868, 211869
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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