Events

Recall of 3M ESPE Stainless Steel Primary Molar Crowns

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

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
    57115
  • Event Risk Class
    Class 3
  • Event Number
    Z-0463-2011
  • Event Initiated Date
    2010-10-06
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95416
  • 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
    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
  • Model / 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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    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
  • Product Description
    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
  • Manufacturer Address
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA