BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0569-2008 · Initiated October 17, 2007

    Recall

    Recall Number
    Z-0569-2008
    Event Number
    45951
    FEI Number
    2110898
    Product Code
    ELZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 17, 2007
    Posted
    January 24, 2008
    Terminated
    October 17, 2008
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, South St Paul, MN, 55144

    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.

    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.

    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.

    Quantity

    975