Device recall
Z-1885-2024: 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0…
FDA device recall · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Recall number (Z-number) | Z-1885-2024 |
|---|---|
| Recall event | 94456 |
| Product | 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker… |
| Product code | PGW |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K221098 |
| FEI number | 3002821504 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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