Events

Recall of 3M ESPE Unitek Primary Stainless Steel Crowns

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company/3m Espe Dental Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65913
  • Event Risk Class
    Class 2
  • Event Number
    Z-2100-2013
  • Event Initiated Date
    2013-08-05
  • Event Date Posted
    2013-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120837
  • Notes / Alerts
    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.
  • Extra notes in the data
    Crown, preformed - Product Code ELZ
  • Reason
    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
  • Model / 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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    3M Company/3m Espe Dental Products, Bldg 0260-02a-11, Saint Paul MN 55144-0001
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA