Events

Retiro De Equipo (Recall) de Fixed Offset Adapter, A642100

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 North America 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
    66609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0362-2014
  • Fecha de inicio del evento
    2013-10-24
  • Fecha de publicación del evento
    2013-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122724
  • 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 inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
  • Acción
    Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.

Device

Fixed Offset Adapter, A642100
  • Modelo / Serial
    Item Number: A-642100    All Serial Numbers.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
  • Descripción del producto
    Fixed Offset Adapter, A-642100. || The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Dirección del fabricante
    Ossur North America Inc, 27051 Towne Centre Dr, Foothill Ranch CA 92610-2804
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA