Device recall
Z-2363-2023: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA device recall · Class II · Medtronic Sofamor Danek USA, Inc
Key facts
| Recall number (Z-number) | Z-2363-2023 |
|---|---|
| Recall event | 92749 |
| Product | CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K |
| Product code | OLO |
| Recalling firm | Medtronic Sofamor Danek USA, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140454 |
| FEI number | 3003120897 |
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