Events

Retiro De Equipo (Recall) de Device Recall LP Rotate Foot System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ossur H / F.

¿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
    70648
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1288-2015
  • Fecha de inicio del evento
    2015-03-04
  • Fecha de publicación del evento
    2015-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134240
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Component, external, limb, ankle/foot - Product Code ISH
  • Causa
    The threads of the outer tube of the shock module of lp rotate are too short, resulting in insecure assembly. use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
  • Acción
    The firm's recall letter states the following instructions: Immediately examine inventory and quarantine product subject to the recall. In addition the firm asks if further distributed to identify the customers and notify them of the recall. The firm states that notification may be enhanced by providing a copy of the letter. The firm states that the recall notice needs to be passed along to all those who need to be aware. The firm also states that if customers are wearing a faulty product that they recommend them scheduling a visit to have the product replaced with a new LP Rotate that is currently available. The firm states that they can also arrange pick-up of defected products. For any questions the firm provides a customer service contact: Jamie Dutter, Senior Customer Service Representative.

Device

Device Recall LP Rotate Foot System
  • Modelo / Serial
    LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland,
  • Descripción del producto
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. || -Low profile foot module with adjustable shock absorber and rotation || with progressive stiffening || -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) || with female pyramid adapter 153 165mm (6 - 6 1/2) || -Male pyramid adapter || -Female pyramid adapter || -Maintenance free, no lubrication required || -Maximum weight: 147kg (325lbs) || -Available in sizes 22-30
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Dirección del fabricante
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA