Events

Retiro De Equipo (Recall) de Device Recall ReSolve Halo Open Back Halo Ring

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 Engineering, 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
    50706
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1508-2009
  • Fecha de inicio del evento
    2008-11-09
  • Fecha de publicación del evento
    2009-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76485
  • 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
    Skull Tong for Traction - Product Code HAX
  • Causa
    Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
  • Acción
    Ossur contacted direct consignees and sub-accounts beginning on November 10 , 2008 via a phone call informing them of the recall, and the reason as stated in the public reason for recall. Consignees were asked to check their inventory for any of the identified products and contact them with this information. The firm developed a telephone script for the customer service representatives to use. Ossur then forwarded a notification letter to the affected customers beginning on November 12, 2008 via US Postal Service. In the event that any of these parts have already been applied to a patient, Ossur advised customers to follow their normal follow-up protocols, ensuring that the ceramic pins are properly fixed in the skull. At the time of the phone calls Ossur did not have sterilized open back replacement rings available; however, they offered their ReSolve Closed Back Halo ring as an alternative. The firm estimated that the normal product offering should be available once again in approximately four to six weeks from the date of the phone call.

Device

Device Recall ReSolve Halo Open Back Halo Ring
  • Modelo / Serial
    Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • Descripción del producto
    ReSolve Halo - Open Back Halo Ring, Model Number: 505400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer
    Ossur Engineering, Inc

Manufacturer

Ossur Engineering, Inc
  • Dirección del fabricante
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA