3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation
3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall with reported adverse events including bracket bond failures and skin irritation or blistering. However, the source does not report hospitalizations or indicators of serious injury severity required for a Severe rating. The confirmed reported harms place this above theoretical risk scenarios.
Plain-English summary
3M Unitek Corporation is recalling Transbond Plus Self-Etching Primer (REF 712-090 and 712-091), an orthodontic bonding etchant and primer. The recall affects approximately 5,873 boxes containing 380,180 individual units distributed worldwide, including across all U.S. states and to international markets.
The recall was initiated due to an increase in complaints of bracket bond failures and skin irritation or blistering reported by users of the product.
The affected lot numbers are 11093917, 11106533, 11120254, 11153742, 11155372, and 11173412 for product 712-090, and 11165780 and 11165793 for product 712-091. Orthodontists and dental professionals should verify their lot numbers against the recall information.
The recalled product
- 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.
- Manufacturer
- 3M Unitek Corporation
Distribution
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