Device recall
Z-2529-2020: PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage…
FDA device recall · Class II · TeDan Surgical Innovations LLC
Key facts
| Recall number (Z-number) | Z-2529-2020 |
|---|---|
| Recall event | 85830 |
| Product | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. |
| Product code | LXH |
| Recalling firm | TeDan Surgical Innovations LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2022 |
| FEI number | 3005726885 |
At a glance
- None 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