Device recall
Z-0397-2010: FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III…
FDA device recall · Class II · Surgical Devices/Covidien
Key facts
| Recall number (Z-number) | Z-0397-2010 |
|---|---|
| Recall event | 53694 |
| Product | FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product code FS214RC; Manual Release for FlexShaft II & III, product code MR14. |
| Product code | GDW |
| Recalling firm | Surgical Devices/Covidien |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2010 |
| 510(k) numbers | K021249 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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