Events

Retiro De Equipo (Recall) de Device Recall Tapered SwissPlus Implant 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 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
    76746
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1823-2017
  • Fecha de inicio del evento
    2017-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154079
  • 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
    It was manufactured with the minor diameter of the internal thread that is below specification.
  • Acción
    A customer letter was sent on 3/20/17 to inform customers that Zimmer Biomet is recalling a single lot of the Tapered SwissPlus 3.7mmD Implant, Lot No. 63498673. The letter informs customers that the recall is due to one (1) lot of part number SPB10 (lot 63498673) that was manufactured with the minor diameter of the internal thread below specification. This condition may cause mating issues with some screws. The condition occurs when the screw used has a minor thread diameter that is closer to the maximum allowed diameter (maximum material condition). However, screws closer to the least material condition will still fit into the implant. Customers with questions or concerns are instructed to call the customer call center at 1-800-854-7091 between 8:00 am and 5:00pm EST, Monday through Friday. Customers are also instructed to email to corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall Tapered SwissPlus Implant System
  • Modelo / Serial
    Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide: ZA, FR, IT, IR
  • Descripción del producto
    Tapered SwissPlus Implant System, Model No. SPB10
  • 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