Recall Z-0797-2025 ยท KLE Agent, Tooth Bonding, Resin
3M Unitek Corporation
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.
| Date | Jan 2, 2025 (initiated Nov 26, 2024) |
| Status | Open, Classified |
| Reason | Due to an increase of complaints for bracket bond failures and skin irritation or blistering. |
| Root cause | Process control |
| 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 c |
| 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 : A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992048 | MODIFICATION OF PROMPT L-POP Espe Dental AG, Aug 16, 1999 |