Events

Retiro De Equipo (Recall) de Device Recall Ankle Traction Boot

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 Allen Medical Systems, 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
    64509
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0959-2013
  • Fecha de inicio del evento
    2013-02-28
  • Fecha de publicación del evento
    2013-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116368
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Causa
    Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
  • Acción
    Allen Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken. Customers were instructed to: 1. Immediately remove from service your Allen Traction Boot with the serial number(s) XXXXX 2. Contact Allen Medical Customer Service at (800) 433-5774 for an RMA number and instructions to return your Allen Traction Boot for inspection and repair if necessary. There will be no cost to you. 3. Return your Allen Traction Boot to Allen Medical as soon as possible. In order to minimize the inconvenience, we will repair your Allen Traction Boot and return the device to you within 48 hours of receipt.

Device

Device Recall Ankle Traction Boot
  • Modelo / Serial
    A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.
  • Descripción del producto
    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
  • Manufacturer
    Allen Medical Systems, Inc.

Manufacturer

Allen Medical Systems, Inc.
  • Dirección del fabricante
    Allen Medical Systems, Inc., One Post Office Square, Acton MA 01720
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA