Transbond Plus recallZ-0797-2025 · 3M Unitek Corporation · initiated Nov 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Unitek Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0797-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 26, 2024
- Posted by the FDA
- Jan 2, 2025
- Recalling firm
- 3M Unitek Corporation
- Quantity
- 5,873 boxes (380,180 individual L-pops)
- Product code
- KLE
- FDA submissions
- K992048
- 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.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Transbond™ Plus 712-0903m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall4 reports
- Transbond™ Plus 712-0913m Unitek Corporation · AGENT, TOOTH BONDING, RESIN1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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