Device recall
Z-2881-2018: Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product…
FDA device recall · Class II · Back 2 Basics Direct LLC
Key facts
| Recall number (Z-number) | Z-2881-2018 |
|---|---|
| Recall event | 80639 |
| Product | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic… |
| Product code | NKB |
| Recalling firm | Back 2 Basics Direct LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2018 |
| 510(k) numbers | K150184 |
| FEI number | 3011170426 |
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