Events

Retiro De Equipo (Recall) de OTTO BOCK Kenevo knee joints

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 Product.

¿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
    79019
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0815-2018
  • Fecha de inicio del evento
    2017-09-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161206
  • 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 products gmbh has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. when used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened according to the labeled torque specification, and the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. there have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. in the us market and in canada, labeling requires a condition based service at three years. in the rest of the world, a mandatory two year service interval is specified. only the devices in distribution in the united states and canada are affected by this action.
  • Acción
    On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458  Option 1 Loaner Service: (800) 328-3458  Option 3, then Option 1

Device

OTTO BOCK Kenevo knee joints
  • Modelo / Serial
    Serial Numbers:  201520028, 201520027, 20150026, and 201530040.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
  • Descripción del producto
    OTTO BOCK Kenevo knee joints Model 3C60=ST
  • Manufacturer
    Otto Bock Healthcare Product

Manufacturer

Otto Bock Healthcare Product
  • Dirección del fabricante
    Otto Bock Healthcare Product, Brehmstrase 16, Vienna Austria
  • Empresa matriz del fabricante (2017)
    Otto Bock Holding Gmbh & Co. Kg
  • Source
    USFDA