Events

Retiro De Equipo (Recall) de Device Recall Torque Limiting Handle (Aspen/ Alpine)

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 Biomet Spine, 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
    70832
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1466-2015
  • Fecha de inicio del evento
    2015-03-12
  • Fecha de publicación del evento
    2015-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135027
  • 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
    Wrench - Product Code HXC
  • Causa
    Biomet is recalling the lineum hf torque handle limit (lineum) and torque limiting handle (aspen/ alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
  • Acción
    Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.

Device

Device Recall Torque Limiting Handle (Aspen/ Alpine)
  • Modelo / Serial
    538133,538134,548080,550475,552169,553131,553710,558873,567568,569141  Part Number: 6200-1109 2009300344 to 2009300543  2009300544 to 2009300643  2009300644 to 2009300743  2009300744 to 2009300843  2009300844 to 2009300993  2009411328 to 2009411377  2010082160 to 2010082257  2010152507 to 2010152571  2010373025 to 2010373174
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 || Product Usage: || Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Dirección del fabricante
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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