Events

Retiro De Equipo (Recall) de Device Recall MTX Dental Implant

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 Dental 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
    78667
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1190-2018
  • Fecha de inicio del evento
    2017-11-29
  • Fecha de publicación del evento
    2018-03-05
  • 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=160090
  • 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
    Two lots of the tapered screw-vent implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
  • Acción
    On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.

Device

Device Recall MTX Dental Implant
  • Modelo / Serial
    Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
  • Descripción del producto
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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