Events

Retiro De Equipo (Recall) de Device Recall LOCATOR Implant Attachment 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 Zest Anchors 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
    67315
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0935-2014
  • Fecha de inicio del evento
    2014-01-16
  • Fecha de publicación del evento
    2014-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125247
  • 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
    Zest anchors, llc is voluntarily recalling specific lots of locator¿ implant attachment systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 n-cm. it was recently noted by zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommend.
  • Acción
    Zest Anchors, LLC initiated this recall by sending customers recall notification letter on 01/16/2014 via FedEx overnight. The customer notification letter, titled, "IMPORTANT: MEDICAL DEVICE VOLUNTARY RECALL NOTICE", informed customers of the recall, reason for voluntary recall, product information with part numbers and lot numbers, actions to be taken, and contact information. The customer notification letter was accompanied by a response form titled "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement & Receipt Form".

Device

Device Recall LOCATOR Implant Attachment System
  • Modelo / Serial
    Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893.   Since the LOCATOR¿ Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in Ohio and Switzerland.
  • Descripción del producto
    LOCATOR¿ Implant Attachment System. || The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. || FDA 510(k): K994257, K072878
  • Manufacturer
    Zest Anchors LLC

Manufacturer

Zest Anchors LLC
  • Dirección del fabricante
    Zest Anchors LLC, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Source
    USFDA