Events

Rappel de Device Recall 3M 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 - Health Care Business.

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
    66509
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0428-2014
  • Date de mise en oeuvre de l'événement
    2013-06-05
  • Date de publication de l'événement
    2013-11-27
  • 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=122719
  • 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 is recalling specific lots of 3m espe unitek primary stainless steel crowns - series ur4 contain ll3 crowns which are incorrectly labeled as ur4 crowns.
  • Action
    3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-800-634-2249. For questions regarding this recall call 651-733-5718.

Device

Device Recall 3M Unitek" Primary Stainless Steel Crowns
  • Modèle / numéro de série
    Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
  • Description du dispositif
    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns || 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 - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Adresse du fabricant
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA