Events

Retiro De Equipo (Recall) de Stryker Triathlon Tibial Alignment Ankle Clamp EM

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
    17924
  • Fecha de inicio del evento
    2015-02-27
  • 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 orthopaedics carried out a recall for product correction in july 2013 due to complaints associated with cracks or fracture of the plastic triathlon tibial alignment ankle clamp (old design). this issue may lead to potential complications during surgery in the event a replacement sterile ankle clamp is required mid-procedure, which may create a delay exceeding 30 minutes in duration. stryker will organise the swap out of any old plastic clamps for the new metal clamps.
  • Acción
    Product to be exchanged

Device

Stryker Triathlon Tibial Alignment Ankle Clamp EM
  • Modelo / Serial
    Model: Catalogue Number: 65412609. Affected Kits: 65418002-T, 65418030-T, TRIAR36PREP-T, WKSHP65418002-T & SHAPECONV-T, Affected: Lot Numbers: Lots prior to X9L06
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

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