Device recall
Z-2344-2012: Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-2344-2012 |
|---|---|
| Recall event | 63008 |
| Product | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***"… |
| Product code | GWF |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 26, 2013 |
| 510(k) numbers | K083124 |
| FEI number | 1045254 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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