Device recall
Z-0797-2025: 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091…
FDA device recall · Class II · 3M Unitek Corporation
Key facts
| Recall number (Z-number) | Z-0797-2025 |
|---|---|
| Recall event | 95841 |
| 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. |
| Product code | KLE |
| Recalling firm | 3M Unitek Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K992048 |
| FEI number | 2020467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database