Events

Retiro De Equipo (Recall) de Device Recall Zimmer Periarticular Locking Plate 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, 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
    68657
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2131-2014
  • Fecha de inicio del evento
    2014-06-10
  • Fecha de publicación del evento
    2014-07-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128400
  • 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
    A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
  • Acción
    Zimmer sent an Urgent Medical Device Recall letter dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They instructed their distributors to do the following: 1. Please locate, quarantine, and return the affected product (part number 00-2358-014-04; lot 62276042) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager and Surgeon letter directly. Additionally, Risk Managers and Surgeon that were identified via invoice data will also receive a letter directly. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7.If after reviewing this notification you have questions or concerns, please call 1-877-946-2761. They instructed the Surgeons and Risk Managers to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Inspect inventory for part number 00-2358-014-04; lot number 62276042. Quarantine the device and contact your Zimmer sales representative to remove and return the affected device. 3. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.

Device

Device Recall Zimmer Periarticular Locking Plate System
  • Modelo / Serial
    Part Number 00-2358-014-04; lot 62276042
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
  • Descripción del producto
    Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, 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