Events

Rappel de 3M ESPE Stainless Steel Primary Molar 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 / Medical Division.

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
    57115
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0463-2011
  • Date de mise en oeuvre de l'événement
    2010-10-06
  • Date de publication de l'événement
    2010-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95416
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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
  • Adresse du fabricant
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA