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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.

FDA Recall Z-0797-2025 · Posted 2025-01-02

Recalling Firm3M Unitek Corporation
Recall StatusOpen, Classified
Product CodeKLE
Date Initiated2024-11-26
Product Quantity5,873 boxes (380,180 individual L-pops)

Reason for Recall

Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

Firm 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.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992048MODIFICATION OF PROMPT L-POPEspe Dental AG · 1999-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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