Device recall
Z-1017-2023: Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000…
FDA device recall · Class II · Align Technology Inc
Key facts
| Recall number (Z-number) | Z-1017-2023 |
|---|---|
| Recall event | 91320 |
| Product | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 |
| Product code | PNN |
| Recalling firm | Align Technology Inc |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K220287 |
| FEI number | 3002519584 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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