Device recall
Z-1402-2011: Stryker Navigation System - iNtellect Cranial Software, Part number…
FDA device recall · Class II · Stryker Instruments Division of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1402-2011 |
|---|---|
| Recall event | 57487 |
| Product | Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking… |
| Product code | HAW |
| Recalling firm | Stryker Instruments Division of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2011 |
| 510(k) numbers | K062640 |
| FEI number | 1811755 |
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