Device recall
Z-2092-2014: Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-2092-2014 |
|---|---|
| Recall event | 68667 |
| Product | Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3). |
| Product code | NKB |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2014 |
| 510(k) numbers | K131119 |
| FEI number | 2027467 |
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