Events

Retiro De Equipo (Recall) de Device Recall Orthosize

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
    76442
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1495-2017
  • Fecha de inicio del evento
    2017-02-14
  • Fecha de publicación del evento
    2017-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153219
  • 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
    System, image processing, radiological - Product Code LLZ
  • Causa
    Digital templates were created with the incorrect files.
  • Acción
    On 2/14/2017 URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected users and 3rd party users via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for 3rd party users to respond to the formal recall notification. Orthosize Templating Users In approximately 6 weeks you will receive a notice that an update is available for the Orthosize Templating App. Upon selecting the app you will be required to update the app in order to use it. 1. Review this notification and ensure affected personnel are aware its contents. 2. Immediately update the app when the update becomes available. 3. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com Digital Template Users (3rd party) 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately update your systems to include the revised digital templates included with notice. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your records. 4. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 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 corporatequality.postmarket@zimmerbiomet.com

Device

Device Recall Orthosize
  • Modelo / Serial
    Orthosize Templating Version 1.2.6
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Descripción del producto
    Orthosize Templating Version 1.2.6 || Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
  • 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