Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ossur Asia-Pacific.

¿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-00320-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-04
  • 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-00320-1
  • 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
    Ossur is recalling the product due to a defect discovered during assembly (outer tube threads not machined correctly in the cnc process). the threads of the outer tube of the shock module of lp rotate were too short, resulting in insecure assembly to the foot blade. use of the product may cause the patient to fall, as the shock module can become loose from the foot blade.The user may also hear noise coming from the foot module. 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.This recall action was undertaken prior to notifying tga.
  • Acción
    Ossur is replacing all the affected devices with the unaffected units.In case the customers are wearing a faulty product, Ossur is recommending scheduling a visit to have the product replaced with a new LP Rotate that is currently available.

Device

LP rotate, sizes 25-27 cat.1-6.
  • Modelo / Serial
    LP rotate, sizes 25-27 cat.1-6. Model number: E443296Product numbers LRP062, LRF062, LRPU62, and LRFU62. Manufacturing Lot Number: HF141022ARTG Number: 141148
  • Manufacturer
    Ossur Asia-Pacific

Manufacturer

Ossur Asia-Pacific
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    DHTGA