Events

Retiro De Equipo (Recall) de Device Recall SYMBIONIC LEG

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 Americas, Inc..

¿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
    67249
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0936-2014
  • Fecha de inicio del evento
    2012-02-12
  • Fecha de publicación del evento
    2014-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125089
  • 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
    Ossur initiated this recall of the symbionic leg because it may have a possible defect in a small batch of electronics.
  • Acción
    OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ¿ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.

Device

Device Recall SYMBIONIC LEG
  • Modelo / Serial
    Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
  • Descripción del producto
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). || SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25  30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
  • Manufacturer
    Ossur Americas, Inc.

Manufacturer

Ossur Americas, Inc.
  • Dirección del fabricante
    Ossur Americas, Inc., 19762 Pauling, Foothill Ranch CA 92610-2611
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA