Events

Recall of Unitek Stainless Steel Permanent 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
    45951
  • Event Risk Class
    Class 3
  • Event Number
    Z-0569-2008
  • Event Initiated Date
    2007-10-17
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66566
  • 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
    Preformed Crowns - Product Code ELZ
  • Reason
    Mislabeled: unitek stainless steel permanent molar crowns were placed in packaging which incorrectly identified the product as unitek stainless steel primary molar crowns.
  • Action
    3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07. The letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.

Device

Unitek Stainless Steel Permanent Molar Crowns
  • Model / Serial
    Lot #: P060928
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.
  • Product Description
    3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Manufacturer Address
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55144
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA