Device recall
Z-0849-2008: Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031…
FDA device recall · Class II · Medtronic Image Guided Neurologics, Inc.
Key facts
| Recall number (Z-number) | Z-0849-2008 |
|---|---|
| Recall event | 45912 |
| Product | Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, DB-2042-BL, DB-2042-ST… |
| Product code | HAW |
| Recalling firm | Medtronic Image Guided Neurologics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2012 |
| 510(k) numbers | K012366, K022100, K040334 |
| FEI number | 3002684500 |
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