Events

Retiro De Equipo (Recall) de Multiaxial Translating MIS Screw

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 Ebi, 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
    66098
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2214-2013
  • Fecha de inicio del evento
    2013-08-13
  • Fecha de publicación del evento
    2013-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121477
  • 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
    Several complaints were reported to exhibit screw head splay in the cypher mis screw system.
  • Acción
    Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.

Device

Multiaxial Translating MIS Screw
  • Modelo / Serial
    14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029  14-501661 Rod Reducer Lots IT0015 IT0022 IT0023  14-501662 Counter Torque Lots IT0020 IT0021
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
  • Descripción del producto
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. || 1)Screw Tower - REF 14-501660 || 2) Rod Reduce - REF 14-501661 || 3) Counter Torque - REF 14-501662
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Dirección del fabricante
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • 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