Device recall
Z-1518-2021: Omnia Soft Tissue Punch is a dental instrument designed to remove with precision…
FDA device recall · Class II · Omnia SRL
Key facts
| Recall number (Z-number) | Z-1518-2021 |
|---|---|
| Recall event | 87680 |
| Product | Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model… |
| Product code | EME |
| Recalling firm | Omnia SRL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 8, 2023 |
| FEI number | 3004361903 |
At a glance
- None 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