BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated November 26, 2024

    Recall

    Recall Number
    Z-0797-2025
    Event Number
    95841
    Firm
    3M Unitek Corporation
    FEI Number
    2020467
    Product Code
    KLE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 26, 2024
    Posted
    January 2, 2025
    Address
    2724 Peck Rd, Monrovia, CA, 91016-5005

    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.

    Action

    On 11/26/2024, the firm send an URGENT Product Recall letter via email to customers informing them that Solventum has received complaints of bracket bonding failures and skin irritation or blistering. Due to a manufacturing issue there is a potential for an increased occurrence of skin irritation/blistering and for reduced bracket bonding strength. Customer are instructed to: 1. Examine their inventory and destroy any affected product lots. Customers may dispose of the product per their facility s requirements. 2. Complete the enclosed Customer Product Acknowledgement Form and e-mail the completed form to [email protected]. Upon receipt of the completed form, Solventum will issue replacement of product. For questions or further assistance - contact Montage customer service at 1-800-397-8118.

    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)