Device recall
Z-0630-2024: KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental…
FDA device recall · Class II · Keystone Industries
Key facts
| Recall number (Z-number) | Z-0630-2024 |
|---|---|
| Recall event | 93522 |
| Product | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011 |
| Product code | MQC |
| Recalling firm | Keystone Industries |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203000 |
| FEI number | 3010002722 |
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