Events

Retiro De Equipo (Recall) de Device Recall Cypher MIS Screw Inserter

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 Ebi, 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
    68526
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1811-2014
  • Fecha de inicio del evento
    2014-05-15
  • Fecha de publicación del evento
    2014-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128143
  • 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
    Screwdriver - Product Code HXX
  • Causa
    The cypher mis screw inserter may exhibit an increased rate of instrument tip failure.
  • Acción
    Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.

Device

Device Recall Cypher MIS Screw Inserter
  • Modelo / Serial
    Catalog Number 14-501669; Lot Number 006731
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the country The Netherlands.
  • Descripción del producto
    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Dirección del fabricante
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA