Events

Retiro De Equipo (Recall) de Device Recall BIOMET 3i LTX DENTAL IMPLANTS

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 3i, 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
    76809
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1701-2017
  • Fecha de inicio del evento
    2017-03-08
  • 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=154241
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier.
  • Acción
    On March 13 Zimmer Biomet contacted their international consignee and asked them to: 1. Review this notification and ensure affected team members 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. a. Return a digital copy to postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1  Inventory Return Certification Form to Biomet 3i. a. For each return, send a copy of Attachment 1 to postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returns box(es) clearly with RECALL. 5. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. If after reviewing this notice you have further questions or concerns please contact us by email at postmarket@zimmerbiomet.com. 1-800-342-5454

Device

Device Recall BIOMET 3i LTX DENTAL IMPLANTS
  • Modelo / Serial
    LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Argentina
  • Descripción del producto
    BIOMET 3i LTX DENTAL IMPLANTS || Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Dirección del fabricante
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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