Device recall
Z-1470-2020: NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product…
FDA device recall · Class III · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1470-2020 |
|---|---|
| Recall event | 84960 |
| Product | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. |
| Product code | JXI |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 10, 2020 |
| 510(k) numbers | K011168 |
| FEI number | 3003418325 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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