Events

Retiro De Equipo (Recall) de Vanguard Complete Knee 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 Zimmer Biomet, 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
    79250
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1011-2018
  • Fecha de inicio del evento
    2017-10-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161749
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
  • Causa
    The affected products are labeled as a 62.5mm left femur; however, the contents are a vanguard 70mm right femur.
  • Acción
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: rgarequest@zimmerbiomet.com-specify "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Device

Vanguard Complete Knee System
  • Modelo / Serial
    Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: FL, WI, MD, MO, and MI.
  • Descripción del producto
    Vanguard CR Porous Femoral 62.5mm (Left Femur) || For use in total knee arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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