Events

Retiro De Equipo (Recall) de Device Recall Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft

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
    71877
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2759-2015
  • Fecha de inicio del evento
    2015-07-22
  • Fecha de publicación del evento
    2015-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139262
  • 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 interlaminal - Product Code KWP
  • Causa
    Biomet has initiated a recall on biomet spine lineum occ starter flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
  • Acción
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 7/23/2015 to their Consignees/Customers via certified letter. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of device; remove from circulation; carefully follow instructions on enclosed "Response Form" and complete and return via fax to 303.501.8444; if you have further distributed these devices to medical facilities, you MUST notify them of this action; and return device and form to Zimmer Biomet Spine, 310 Interlocken Pkwy, Ste 120, Broomfield, CO 80021. Questions related to this notice should be directed to the Quality Engineer at 303-501-8457 Monday through Friday, 8 a.m. to 5 p.m. MST.

Device

Device Recall Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft
  • Modelo / Serial
    P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
  • Descripción del producto
    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. || The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
  • 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