Device recall
Z-0546-2020: Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
FDA device recall · Class III · SPINEART SA
Key facts
| Recall number (Z-number) | Z-0546-2020 |
|---|---|
| Recall event | 84219 |
| Product | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures |
| Product code | MAX |
| Recalling firm | SPINEART SA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K153621 |
| FEI number | 3007728266 |
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