Device recall
Z-1862-2025: GM Helix Acqua Implant, Article Number: 140.984
FDA device recall · Class II · Straumann USA LLC
Key facts
| Recall number (Z-number) | Z-1862-2025 |
|---|---|
| Recall event | 96806 |
| Product | GM Helix Acqua Implant, Article Number: 140.984 |
| Product code | DZE |
| Recalling firm | Straumann USA LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163194 |
| 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