Device recall
Z-2347-2010: NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are…
FDA device recall · Class II · Synthes USA (HQ), Inc.
Key facts
| Recall number (Z-number) | Z-2347-2010 |
|---|---|
| Recall event | 56323 |
| Product | NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. |
| Product code | NQP |
| Recalling firm | Synthes USA (HQ), Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2010 |
| 510(k) numbers | K061774, K072685 |
| FEI number | 3005180112 |
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