Events

Retiro De Equipo (Recall) de Device Recall NCB Polyaxial Locking Plate System NCB screws

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
    62499
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2187-2012
  • Fecha de inicio del evento
    2012-07-13
  • Fecha de publicación del evento
    2012-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110764
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Zimmer investigation following a complaint found one lot of ncb polyaxial locking plate system ncb screws, 26mm, distributed in the united states contained incorrect 32 mm screws.
  • Acción
    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 13, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the implicated lot in their inventory and user accounts; return all packaged units of this lot; and provide Zimmer with the name, complete mailing address, and phone number of each user facility and surgeon that have used the product via E-mail to dawn.kindle@zimmer.com. Zimmer will send a follow-up Urgent Recall notification to these sub-accounts with instructions to verify the screw length of any screws already in the implant rack inventory prior to use in surgery. All implicated product is to be returned. The customers were also instructed to complete and return the Inventory Return Certification form to Zimmer via fax at +1-574-372-4265. If you have any questions about this correction and/or product removal, contact Zimmer at +1-877-946-2761.

Device

Device Recall NCB Polyaxial Locking Plate System NCB screws
  • Modelo / Serial
    Part number 02.03155.026, lot 2649941
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
  • Descripción del producto
    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile || Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
  • 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