Device recall
Z-1506-2020: DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These…
FDA device recall · Class II · TeDan Surgical Innovations LLC
Key facts
| Recall number (Z-number) | Z-1506-2020 |
|---|---|
| Recall event | 84252 |
| Product | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. |
| 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