Events

Retiro De Equipo (Recall) de Device Recall Epic Extremity Plate System

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 Epic Extremity, LLC.

¿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
    79824
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1875-2018
  • Fecha de inicio del evento
    2018-03-20
  • 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=163817
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    There is an error in the caddy artwork that misidentifies a specific plate and screw.
  • Acción
    Notification letters were sent on 3/20/18. The letters instructed customers to: We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession. Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to dschwartzbauer@EPICextremity.com. The notification letter included photographs of products to indicate errors in labeling.

Device

Device Recall Epic Extremity Plate System
  • Modelo / Serial
    Catalog Number: 2111-1010 Lot: 51461
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The products were distributed to the following US states: FL, PA, and VA.
  • Descripción del producto
    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
  • Manufacturer
    Epic Extremity, LLC

Manufacturer

Epic Extremity, LLC
  • Dirección del fabricante
    Epic Extremity, LLC, 120 Marguerite Dr Ste 301, Cranberry Twp PA 16066-5007
  • Source
    USFDA