Events

Retiro De Equipo (Recall) de Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.

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 Highland Metals, 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
    67378
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0922-2014
  • Fecha de inicio del evento
    2013-12-13
  • Fecha de publicación del evento
    2014-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125369
  • 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
    Wire, orthodontic - Product Code DZC
  • Causa
    Labeling issue: product labeled as "upper" may contain "lower" archwires with a red midline mark. product labeled ad "lower" may contain "upper" archwires with a black midline mark.
  • Acción
    Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.

Device

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.
  • Modelo / Serial
    Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • Descripción del producto
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.16 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.

Manufacturer

Highland Metals, Inc.
  • Dirección del fabricante
    Highland Metals, Inc., 419 Perrymont Ave, San Jose CA 95125-1445
  • Source
    USFDA