Device recall
Z-1504-2020: D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR…
FDA device recall · Class II · TeDan Surgical Innovations LLC
Key facts
| Recall number (Z-number) | Z-1504-2020 |
|---|---|
| Recall event | 84252 |
| Product | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and… |
| Product code | LXH |
| Recalling firm | TeDan Surgical Innovations LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2021 |
| 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