medical Class II Updated 2025-01-08

3M Unitek Corporation recalls 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (1

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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