Events

Retiro De Equipo (Recall) de Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder

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 Zimmer, 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
    62137
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1933-2012
  • Fecha de inicio del evento
    2012-06-05
  • Fecha de publicación del evento
    2012-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109900
  • 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
    Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. the complaint investigation showed the hex mating feature of the set screw was broken and material missing. there were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we.
  • Acción
    The firm, Zimmer Spine, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the notification and ensure they are aware of the content; to immediately remove and discontinue use of Pivoting Percutaneous Rod Holder (part number 3564-1) from Pathfinder NXT instrument sets in their possession and follow the PathFinder NXT Surgical Technique; to notify their Zimmer Spine customer service representative to obtain return authorization; and return the complete Surgeon Contact Certification Form within 10 working days from receipt of notification to ronald.musselman@zimmer.com or Fax to 1-512-258-0995. If you have any questions, call Zimmer Spine Customer Service at 866-774-6368.

Device

Device Recall PathFinder NXT Pivoting Percutaneous Rod Holder
  • Modelo / Serial
    Part number 3564-1; all lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
  • Descripción del producto
    PathFinder NXT Pivoting Percutaneous Rod Holder || This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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