Events

Retiro De Equipo (Recall) de Device Recall Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

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
    77171
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2125-2017
  • Fecha de inicio del evento
    2017-05-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155149
  • 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
    Implant direct sybron manufacturing is recalling the legacy full-contour abutment 3.5mmd assembly because it may be out of implant direct specification.
  • Acción
    Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may lead to the possibility of the abutment not seating properly on the implant, and if undetected may lead to micro-leakage and a possible infection to the patient. Customers are instructed to complete and return the Acknowledgement and Recall Return form within 48 hrs. Customers with any questions are instructed to contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Device

Device Recall Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
  • Modelo / Serial
    89103, 83493, 78986
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
  • Descripción del producto
    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
  • 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