Events

Retiro De Equipo (Recall) de 3M ESPE Unitek Primary Stainless Steel Crowns

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 3M Company/3m Espe Dental Products.

¿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
    65913
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2100-2013
  • Fecha de inicio del evento
    2013-08-05
  • Fecha de publicación del evento
    2013-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120837
  • 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
    Crown, preformed - Product Code ELZ
  • Causa
    3m espe is recalling unitek primary stainless steel crowns (first primary ul4) because these products have been manufactured with the incorrect marginal contour edge.
  • Acción
    3M ESPE sent a 3M "Voluntary Recall" letter dated August 1, 2013 to all affected customers. Separate letters were addressed to distributors and doctors. The letters described the product affected by the recall, problem and actions to be taken. The doctors were advised to complete the attached inventory checklist and call the 3M ESPE Dental Products Customer Care Center at 1-800-634-2249. Select option #1 to arrange for return and replacement of your product. Distributors were advised to quarantine and return the product and not to further distribute it. For product return they should contact 3M ESPE Dental Products Customer Service at 1-800-237-1650. If the product was further distributed they ask that they inform them of the recall. A letter was prepared that can be used for their communication to customers. for additional questions they should contact 651-733-7767.

Device

3M ESPE Unitek Primary Stainless Steel Crowns
  • Modelo / Serial
    Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695  Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.
  • Descripción del producto
    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). || Product Usage: || Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
  • Manufacturer
    3M Company/3m Espe Dental Products

Manufacturer

3M Company/3m Espe Dental Products
  • Dirección del fabricante
    3M Company/3m Espe Dental Products, Bldg 0260-02a-11, Saint Paul MN 55144-0001
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA