Events

Retiro De Equipo (Recall) de Device Recall Zyston Transform TLIF 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 Zimmer Biomet Spine, 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
    74687
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2398-2016
  • Fecha de inicio del evento
    2016-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148222
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Zimmer bioment spine, inc. announces a voluntary field action for the zyston¿ transform instrument case and zyston¿ transform implant kit because the locking mechanism on the implant is not functioning as intended.
  • Acción
    Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.

Device

Device Recall Zyston Transform TLIF System
  • Modelo / Serial
    Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • Descripción del producto
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
  • Manufacturer
    Zimmer Biomet Spine, Inc

Manufacturer

Zimmer Biomet Spine, Inc
  • Dirección del fabricante
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • 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