Events

Retiro De Equipo (Recall) de Device Recall Biomet Spine Durango Anchored ALIF Plate

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
    69615
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0220-2015
  • Fecha de inicio del evento
    2011-03-09
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131149
  • 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
    Biomet spine, llc. announces voluntary recall of durango anchored alif plate due to the set screw component potentially becoming dislodged from the plate assembly.
  • Acción
    Biomet notified customers by phone on March 9, 2011 to return the affected product.

Device

Device Recall Biomet Spine Durango Anchored ALIF Plate
  • Modelo / Serial
    Lot numbers L532655, L532690, Product code 8503XXXX
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
  • Descripción del producto
    LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. || Product Usage: || The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
  • 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