Events

Retiro De Equipo (Recall) de Otto Bock Modular 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 Bock,Otto,Orthopedic Ind,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
    50486
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0537-2010
  • Fecha de inicio del evento
    2008-10-28
  • Fecha de publicación del evento
    2009-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75488
  • 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
    External Limb Knee Joint Component - Product Code ISY
  • Causa
    Otto bock health care lp has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. this can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
  • Acción
    Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.

Device

Otto Bock Modular Knee Joint,
  • Modelo / Serial
    Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
  • Descripción del producto
    Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • Dirección del fabricante
    Bock,Otto,Orthopedic Ind,Inc, Two Carlson Parkway North, Suite 100, Minneapolis MN 55447
  • Source
    USFDA