BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0535-2014 · Initiated November 21, 2013

    Recall

    Recall Number
    Z-0535-2014
    Event Number
    66944
    Firm
    3M Company Health Care Business 3M Center
    FEI Number
    2110898
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 21, 2013
    Posted
    December 18, 2013
    Terminated
    June 2, 2014
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144

    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.

    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.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.

    Quantity

    1977 kits