Device recall
Z-1394-2022: Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA device recall · Class III · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1394-2022 |
|---|---|
| Recall event | 90448 |
| Product | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 |
| Product code | FQA |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| FEI number | 1811755 |
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