Events

Retiro De Equipo (Recall) de Device Recall SwishTapered 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 Implant Direct Sybron Manufacturing, 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
    79396
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1167-2018
  • Fecha de inicio del evento
    2018-01-19
  • 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=162206
  • 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
    The extender that is packaged with the swishtapered" and swishplus" implant may have been packaged in the incorrect position (upside down in the plastic retainer).
  • Acción
    Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Device

Device Recall SwishTapered Implant
  • Modelo / Serial
    Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
  • Descripción del producto
    SwishTapered Implant || Intended for use in support for fixed bridgework.
  • Manufacturer
    Implant Direct Sybron Manufacturing, LLC

Manufacturer

Implant Direct Sybron Manufacturing, LLC
  • Dirección del fabricante
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA