Events

Retiro De Equipo (Recall) de Legacy(TM) 3 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
    78350
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0185-2018
  • Fecha de inicio del evento
    2017-10-10
  • 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=159290
  • 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
    One reported complaint and discovered that the outer vial was out of round and undersized. therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. as a result, the cap could possibly not be screwed on properly and the sterilization compromised.
  • Acción
    The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customers were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. Please share this information with your staff and retain this notification as part of your documentation. Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425."

Device

Legacy(TM) 3 Implant
  • Modelo / Serial
    Lot Number: 79607
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
  • Descripción del producto
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 || This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment 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