Events

Retiro De Equipo (Recall) de Device Recall Trinica

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 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
    29908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0040-05
  • Fecha de inicio del evento
    2004-08-24
  • Fecha de publicación del evento
    2004-10-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34756
  • 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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Causa
    To date, there has been one complaint reported. during a trinica surgical case, the surgeon was provided a standard disposable, trinica drill bit (part number 07.00166.001) for use with the trinica all through one drill guide instrumentation, instead of the all through one drill bit. this enabled the physician to drill a few millimeters further than expected.
  • Acción
    The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.

Device

Device Recall Trinica
  • Modelo / Serial
    Serial Numbers: ATO-001 through ATO-0082
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.
  • Descripción del producto
    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
  • Manufacturer
    Zimmer Spine, Inc.

Manufacturer

Zimmer Spine, Inc.
  • Dirección del fabricante
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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