3M Unitek Corporation: Device Recall
Recall #Z-0797-2025 · 11/26/2024
Recall Details
- Recall Number
- Z-0797-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- 3M Unitek Corporation
- Status
- Ongoing
- Date Initiated
- 11/26/2024
- Location
- Monrovia, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,873 boxes (380,180 individual L-pops)
Reason for Recall
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Product 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.
Distribution Pattern
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.