Events

Recall of Device Recall Imprint II and Paradigm impression material

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

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
    66944
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2014
  • Event Initiated Date
    2013-11-21
  • Event Date Posted
    2013-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124262
  • 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
    Material, impression - Product Code ELW
  • Reason
    Specific lots of imprint ii and paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
  • Action
    3M ESPE sent an Voluntary Recall Notification Letter dated November 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to: 1) Review your inventory and identify any products from these lot numbers 2) Quarantine products from these lots and do not further distribute 3) If you have shipped any products from these lots to your customers, inform them of this voluntary recall using the attached Dear Doctor Letter and Inventory Checklist 4) To return and replace product from these lots, contact 3M ESPE Dental Products Customer Service at 1-800-237-1650 If you have any questions, please contact the above number for assistance. Once again, we sincerely apologize for any inconvenience this may cause you.

Device

Device Recall Imprint II and Paradigm impression material
  • Model / Serial
    Lot codes: N510884, N510889, and N511952
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
  • Product Description
    3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. || Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA