Events

Retiro De Equipo (Recall) de Damon 3MX Bicuspid Bracket

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 Ormco/Sybronendo.

¿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
    63296
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0120-2013
  • Fecha de inicio del evento
    2012-04-24
  • Fecha de publicación del evento
    2012-10-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113433
  • 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
    Bracket, metal, orthodontic - Product Code EJF
  • Causa
    The firm initiated the recall as a result of a misidentification of the brackets. damon 3mx bicuspid brackets are produced with a purple colored id dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored id dots, which identified them as maxillary central incisor brackets.
  • Acción
    Ormco/Sybronendo sent an Urgent Medical Device Recall letter via USPS 1~1 class mail, on April 24, 2012 to all consignees. Consignees were sent an updated customer notification via USPS lSI class mail on June 28, 2012. The letters identified the affected product, problem and actions to be taken. Consignees were instructed to complete the Acknowledgement/Return Form and to return any affected product in their inventory. Customers were instructed to contact Ormco Customer Care at 1-800-854-1741 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.

Device

Damon 3MX Bicuspid Bracket
  • Modelo / Serial
    Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.
  • Descripción del producto
    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 || Product Usage: || Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Dirección del fabricante
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA