Events

Retiro De Equipo (Recall) de Stryker Trident Acetabular Shell, surgical protocol

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
    17444
  • Fecha de inicio del evento
    2014-10-01
  • 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 a report from the field of incorrect product information identified in literature: trident surgical protocol (lsp69) and literature: trident product reference guide (lx3prg)., lsp69 and lx3prg each contain a table which references an incorrect number of screw holes for trident hemispherical ha cluster shell sizes 44mm - 50mm. these size shells have only 3 screw holes, not 5 as stated in the table.
  • Acción
    Instructions for use to be updated

Device

Stryker Trident Acetabular Shell, surgical protocol

Manufacturer

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