Device recall
Z-0512-2022: Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant…
FDA device recall · Class II · Straumann USA LLC
Key facts
| Recall number (Z-number) | Z-0512-2022 |
|---|---|
| Recall event | 89321 |
| Product | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 |
| Product code | DZE |
| Recalling firm | Straumann USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2025 |
| 510(k) numbers | K203382 |
| FEI number | 1000121052 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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