Device recall
Z-1973-2019: A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part…
FDA device recall · Class II · SpineFrontier, Inc.
Key facts
| Recall number (Z-number) | Z-1973-2019 |
|---|---|
| Recall event | 83166 |
| Product | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) |
| Product code | OVE |
| Recalling firm | SpineFrontier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2020 |
| 510(k) numbers | K172484 |
| FEI number | 3005977257 |
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