Events

Retiro De Equipo (Recall) de Stryker Vitallium Femoral Heads with PCA taper, LFIT V40 taper or V40 taper

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Stryker Howmedica Osteonics.

¿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
    19220
  • Fecha de inicio del evento
    2015-10-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Stryker has received four customer complaints for v40 lfit vitallium femoral heads (manufactured 7-jul-2014 and 15-aug-2014) reporting, at the time of surgery the femoral head could not be assembled with its corresponding v40 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
    Product to be returned to supplier

Device

Stryker Vitallium Femoral Heads with PCA taper, LFIT V40 taper or V40 taper
  • Modelo / Serial
    Model: 6260-5-028, 6260-5-032, 6260-5-132, 6260-5-232, 6260-5-328, 6260-5-332, 6260-5-428, 6260-5-432, 6260-9-028, 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-132 and 6280-0-228, Affected: Manufactured between 7-Jul-2014 and 15-Aug-2014
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA