Device recall
Z-1077-2015: Flyte Togas are components of the Stryker Flyte System and are intended to be…
FDA device recall · Class III · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1077-2015 |
|---|---|
| Recall event | 70332 |
| Product | Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System… |
| Product code | FYA |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 5, 2015 |
| 510(k) numbers | K073017 |
| FEI number | 1811755 |
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