Events

Retiro De Equipo (Recall) de Device Recall Ottobock Pheon 3R62 Knee Joint

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 Otto Bock Healthcare GmbH.

¿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
    71715
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2261-2015
  • Fecha de inicio del evento
    2015-07-16
  • Fecha de publicación del evento
    2015-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138816
  • 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
    Joint, knee, external limb component - Product Code ISY
  • Causa
    Otto bock healthcare gmbh is voluntarily recalling all 3r62 pheon polycentric prosthetic knee joints distributed since february 2014 because the locking function may fail under certain conditions which may result in a fall.
  • Acción
    The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: USRecalls@ottobock.com "Pheon Recall"; fax (801) 974-6718-"Pheon Recall" or mail to: Otto Bock HealthCare LP, ATTN: PHEON RECALL, 3820 W. Great Lakes Drive, Salt Lake City, UT 84120-B7 is re-designing the locking function to prevent this failure from occurring. The re-designed devices will be available for replacement sometime within the next few months. If you have any questions contact Director, Regulatory & Quality Compliance at (801) 974-6618 or email: Lex.Pearce@ottobock.com.

Device

Device Recall Ottobock Pheon 3R62 Knee Joint
  • Modelo / Serial
    The removal affects all devices manufactured and distributed since February 2014.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
  • Descripción del producto
    Ottobock Pheon 3R62 Knee Joint || The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
  • Manufacturer
    Otto Bock Healthcare GmbH

Manufacturer

Otto Bock Healthcare GmbH
  • Dirección del fabricante
    Otto Bock Healthcare GmbH, Max-Nader-Str. #15, Duderstadt Germany
  • Empresa matriz del fabricante (2017)
    Otto Bock Holding Gmbh & Co. Kg
  • Source
    USFDA