Device recall
Z-1823-2020: Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210…
FDA device recall · Class II · U&I CORP.
Key facts
| Recall number (Z-number) | Z-1823-2020 |
|---|---|
| Recall event | 84989 |
| Product | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the… |
| Product code | OVE |
| Recalling firm | U&I CORP. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| 510(k) numbers | K172424 |
| FEI number | 3003200961 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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