Events

Retiro De Equipo (Recall) de Device Recall ROIA Anterior Delivery Device

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 LDR Spine USA, 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
    75068
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0045-2017
  • Fecha de inicio del evento
    2016-08-29
  • Fecha de publicación del evento
    2016-10-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149274
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    The roi-a anterior delivery device t-handle, part number si-roia-0023 has experienced binding of the rotation of the t-handle. there have been no reports of patient injury.
  • Acción
    The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.

Device

Device Recall ROIA Anterior Delivery Device
  • Modelo / Serial
    Lot # 2295101A, 2295101A-R, 2296101A-R
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
  • Descripción del producto
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 || Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
  • Manufacturer
    LDR Spine USA, Inc.

Manufacturer

LDR Spine USA, Inc.
  • Dirección del fabricante
    LDR Spine USA, Inc., 13785 Research Blvd Ste 200, Austin TX 78750-1895
  • 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