Events

Retiro De Equipo (Recall) de Device Recall Polaris Translation Screw 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 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
    66300
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0359-2014
  • Fecha de inicio del evento
    2013-08-22
  • Fecha de publicación del evento
    2013-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121961
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Polaris translation screw failures were recently reported to biomet spine. these failures are generally described as dissociation of the screw head from the shaft of the polaris translation screw.
  • Acción
    Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.

Device

Device Recall Polaris Translation Screw System
  • Modelo / Serial
    Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the  SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution including Puerto Rico.
  • Descripción del producto
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. || Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Dirección del fabricante
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • 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