FDA Device recall Z-0797-2025
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 orth…
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of 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 orth… by 3m Unitek, citing due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0797-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-26 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | 3m Unitek |
| Distribution | US |
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.
Reason
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Identifiers
| code_info | Product Number: 712-090 UDI-DI code: 00652221109170 Lot Numbers: 11093917 11106533 11120254 11153742 11155372 11173412…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0797-2025%22
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