Events

Retiro De Equipo (Recall) de Ossur LP rotate, sizes 25-27 cat.1-6

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 Ossur HF.

¿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
    18538
  • Fecha de inicio del evento
    2015-07-23
  • 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: Christchurch Artificial Limb Centre, 330 Burwood Road, Christchurch 8083
  • Causa
    Ossur is recalling this device due to the outer tube threads not being machined correctly. use of the affected product may cause the patient to fall, as the shock module can become loose from the foot blade. the failure could possibly be noticed by users as they will feel looseness on ankle foot device. if use is continued, connection of shock adapter to foot blade might break and user may fall.
  • Acción
    Product to be returned to supplier

Device

Ossur LP rotate, sizes 25-27 cat.1-6
  • Modelo / Serial
    Model: Product numbers LRP062, LRF062, LRPU62, and LRFU62, Affected: Manufacturing Lot Number: HF141022
  • Manufacturer
    Ossur HF

Manufacturer

Ossur HF
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    NZMMDSA