Events

Retiro De Equipo (Recall) de Biomet The Polaris Spinal System; Shortened Plug Driver

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
    66654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0411-2014
  • Fecha de publicación del evento
    2013-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122904
  • 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
    Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
  • Acción
    Biomet sent an Urgent Medical Device Recall Letters/Fax Back Response Form dated September 24, 2013, via Fed Ex. The customer is asked to examine their inventory and return the recalled product following the attached instructions. The Fax Back Response Form should be completed and returned to 973-887-1347 prior to the return of the product. Any questions please call (973) 299-9300 x 2162.

Device

Biomet The Polaris Spinal System; Shortened Plug Driver
  • Modelo / Serial
    Device listing # D090878 Catalog # LV00407 Lot #184090
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to CA
  • Descripción del producto
    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 || The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
  • 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