Events

Retiro De Equipo (Recall) de Thinflap System Case

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 Biomet Microfixation, LLC.

¿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
    72366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0137-2016
  • Fecha de inicio del evento
    2015-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140803
  • 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, cranioplasty, preformed, alterable - Product Code GWO
  • Causa
    The lids on implant caddies within p/n 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
  • Acción
    Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Follow¿up communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following: 1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice. 2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays. 3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice. RETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid DO NOT RETURN NEW LID: Part numbert 15-5001-18 or 1~5001-18 respectively 4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products. Customers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.

Device

Thinflap System Case
  • Modelo / Serial
    Lot Code # 101465 Model # 19-5000
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
  • Descripción del producto
    Thinflap System Case || The cases hold surgical instrumentation in place during handling and storage.
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Dirección del fabricante
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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