Events

Retiro De Equipo (Recall) de Microfil Composite Instruments

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 Almore International 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
    76963
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2069-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154721
  • 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
    Carver, dental amalgam, operative - Product Code EKH
  • Causa
    Microfil composite instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. these products are not sterile and they are intended to be sterile prior to each use.
  • Acción
    Almore International sent an urgent medical device recall letter via certified mail on April 20, 2017 to consignees informing them of the labeling error and that the device is not sterile upon receipt. On 5/8/17, the firm expanded the recall and will notify four additional consignees by 5/10/17. Almore will send new replacement label inserts to customers who still have affected device on hand upon request. Distributor should notify downstream customers and/or provides new label inserts to downstream customers as needed. Consignees should send response form to Almore International, Inc. using one of the following methods below: o Fax the completed form to 503-643-9748 or o Send the scanned form via email to info@almore.com or o Mail a copy of the completed form to: Microfil Recall, Almore International Inc. 10950 SW 5th Street, Suite 270 Beaverton, OR. 97005. If consignees have questions please contact Almore International, Inc. at 503-643-6633 Monday through Friday between 9am and 4pm PST.

Device

Microfil Composite Instruments
  • Modelo / Serial
    no lot codes
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distributed - US Nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, and internationally in Canada, Netherlands, and South Korea.
  • Descripción del producto
    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. || It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. || Models: || #96041  Gold Microfil || #96042  Green Microfil || #96043  Blue Microfil || #96044  Set of 3 Microfil (Gold, Green, Blue)
  • Manufacturer
    Almore International Inc

Manufacturer

Almore International Inc
  • Dirección del fabricante
    Almore International Inc, 10950 SW 5th St Ste 270, Beaverton OR 97005-4746
  • Empresa matriz del fabricante (2017)
    Almore International Inc
  • Source
    USFDA