Events

Rappel de 3M ESPE Unitek Primary Stainless Steel Crowns

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par 3M Company/3m Espe Dental Products.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65913
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2100-2013
  • Date de mise en oeuvre de l'événement
    2013-08-05
  • Date de publication de l'événement
    2013-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120837
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Crown, preformed - Product Code ELZ
  • Cause
    3m espe is recalling unitek primary stainless steel crowns (first primary ul4) because these products have been manufactured with the incorrect marginal contour edge.
  • Action
    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
  • Modèle / numéro de série
    Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695  Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    3M Company/3m Espe Dental Products, Bldg 0260-02a-11, Saint Paul MN 55144-0001
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA