Device recall
Z-1597-2015: Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury…
FDA device recall · Class III · Spinal Elements, Inc
Key facts
| Recall number (Z-number) | Z-1597-2015 |
|---|---|
| Recall event | 70950 |
| Product | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the… |
| Product code | NKB |
| Recalling firm | Spinal Elements, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 25, 2015 |
| 510(k) numbers | K071914 |
| FEI number | 3004893332 |
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