BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0463-2011 · Initiated October 6, 2010

    Recall

    Recall Number
    Z-0463-2011
    Event Number
    57115
    FEI Number
    2110898
    Product Code
    ELZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 6, 2010
    Posted
    November 26, 2010
    Terminated
    February 4, 2012
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, Saint Paul, MN, 55144

    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

    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.

    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

    Quantity

    9819