BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

    Recall: Z-0797-2025 · Reported January 8, 2025

    Enforcement

    Recall Number
    Z-0797-2025
    Event ID
    95841
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Unitek Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2025
    Initiation Date
    November 26, 2024
    Classification Date
    January 2, 2025
    Address
    2724 Peck Rd, Monrovia, CA, 91016-5005, United States

    Description

    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

    Reason

    Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

    Code Info

    Product Number: 712-090 UDI-DI code: 00652221109170 Lot Numbers: 11093917 11106533 11120254 11153742 11155372 11173412 Product Number: 712-091 UDI-DI code: 00652221109187 Lot Numbers: 11165780 11165793

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of : Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican, Republic, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Hong Kong, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherland, New Zealand, Norway, Poland, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, and the United Kingdom.

    Quantity

    5,873 boxes (380,180 individual L-pops)