Events

Retiro De Equipo (Recall) de Cypher MIS Screw System

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
    69785
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0909-2015
  • Fecha de inicio del evento
    2014-10-08
  • Fecha de publicación del evento
    2015-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131537
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the cypher mis screw system.
  • Acción
    The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter. If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548.

Device

Cypher MIS Screw System
  • Modelo / Serial
    Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
  • Descripción del producto
    Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. || Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Dirección del fabricante
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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