Events

Retiro De Equipo (Recall) de LFIT V40 Femoral Head

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-00129-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-24
  • 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-00129-1
  • 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 orthopaedics has received three customer complaints for a single lot of a specific size of the 32mm -4 v40 lfit vitallium femoral heads reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion. upon investigation it was found that the female taper of the femoral head was not machined per drawing specifications, leaving a lip protruding approximately 0.007in from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully assembling with the associated male stem trunnion.No adverse consequences or delays to surgery were reported for any of the three complaints.
  • Acción
    No additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. This action has been closed-out on 03/08/2016.

Device

LFIT V40 Femoral Head
  • Modelo / Serial
    LFIT V40 Femoral HeadCatalogue Number: 62609032Lot Number: 48681201ARTG Number: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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