Recall Z-0797-2025
3M Unitek Corporation · initiated November 26, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
Reason for recall
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
FDA-determined cause: Process control
Action taken
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 3MFieldSafetyAction@montage72.com. 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.
Details
- Recall number
- Z-0797-2025
- Initiated
- November 26, 2024
- Posted by FDA
- January 2, 2025
- Product code
- KLE – Agent, Tooth Bonding, Resin
- Quantity
- 5,873 boxes (380,180 individual L-pops)
- 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…
- Recalling firm
- 3M Unitek Corporation, Monrovia, CA