Events

Retiro De Equipo (Recall) de Device Recall Herbst Universal Nut

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 Specialty Appliance Works, Inc..

¿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
    70787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1508-2015
  • Fecha de inicio del evento
    2015-03-09
  • Fecha de publicación del evento
    2015-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135035
  • 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
    Clamp, wire, orthodontic - Product Code ECN
  • Causa
    The universal nut, a component of the orthodontic herbst appliance was made with 416 ss and not the specified 303 ss.
  • Acción
    Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.

Device

Device Recall Herbst Universal Nut
  • Modelo / Serial
    Product No. 91522 and 91523
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
  • Descripción del producto
    LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
  • Manufacturer
    Specialty Appliance Works, Inc.

Manufacturer

Specialty Appliance Works, Inc.
  • Dirección del fabricante
    Specialty Appliance Works, Inc., 4905 Hammond Industrial Dr, Cumming GA 30041-3914
  • Empresa matriz del fabricante (2017)
    Specialty Appliance Works, Inc.
  • Source
    USFDA