Events

Retiro De Equipo (Recall) de 3M ESPE Stainless Steel Primary Molar 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 / Medical Division.

¿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
    57115
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0463-2011
  • Fecha de inicio del evento
    2010-10-06
  • Fecha de publicación del evento
    2010-11-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95416
  • 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
    Unitek stainless steel permanent crowns with product codes 902150, 900213, and 900223, is mislabeled. the crown contained within the package is incorrectly labeled; series ul3 crowns are labeled series ur3 and vice versa. the lid of the package correctly identified the product number and lot. this mislabeling could result in placement on the right side of a crown intended for use on the left, and.
  • Acción
    3M ESPE issued a Device Recall letter dated October 6, 2010 to distributors and dentists. The letter listed the product being recalled including code and lot codes, background information including a picture of the product problem, and the recall procedure. The letter included a template letter to be used by distributors to inform their customers who have received the product. Mislabeled product is to be quarantined and returned to 3M ESPE. 3M ESPE can be contacted at 651 733-1110.

Device

3M ESPE Stainless Steel Primary Molar Crowns
  • Modelo / Serial
    Product Code 900223 (Refill) " Lot codes N161092, N195115, N171401,N172028,N181008  Product Code 900213 (Refill) " Lot codes N161243, N168400, N181006, N186982, N195318  Product Code 902150 (Kit) " Lot Codes N155749, N170175, N193318
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: Throughout USA, including the states of AZ, CA, GA, IL, IN, IA, LA, MA, MN, MO, NV,NJ, NY, NC, PA, TN, TX, WA, and WI. Canada and Dominican Republic
  • Descripción del producto
    3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. || Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 || Product Code 900223, 900213, 902150
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Dirección del fabricante
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA