Events

Retiro De Equipo (Recall) de Zimmer Gender Solutions

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
    75371
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0317-2017
  • 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=150155
  • 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
    Saw, powered, and accessories - Product Code HAB
  • Causa
    Complaints have been reported that the handpiece is inoperable. the investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. an inoperable device may lead to a delay in surgery.
  • Acción
    On 9/28/2016,  URGENT MEDICAL DEVICE FIELD REMOVAL notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Managers and Surgeons Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with quarantining all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility for the initial preventative maintenance and arrange for a loaner device. It is estimated that your handpieces will undergo preventative maintenance sometime between November 2016 and March 2017. 4. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to CPWARFieldAction@zimmerbiomet.com or via fax to 574-372-1683 within three (3) days. b. Retain a copy of the Acknowledgement Form with your field removal records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field removal that are recommended beyond your existing follow up schedule. 3. Complete Attachment 3  Certificate of Acknowledgement. a. Return a digital copy via email to

Device

Zimmer Gender Solutions
  • Modelo / Serial
    Item Number 00-5927-040-00 Serial Number All
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
  • Descripción del producto
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis || Milling Handpiece
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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