Device recall
Z-1438-04: Optima Spinal System and Spinal Hook System, set screw component.
FDA device recall · Class II · U&I America
Key facts
| Recall number (Z-number) | Z-1438-04 |
|---|---|
| Recall event | 29872 |
| Product | Optima Spinal System and Spinal Hook System, set screw component. |
| Product code | MNI |
| Recalling firm | U&I America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2005 |
| 510(k) numbers | K020279, K024096, K031585, K031595 |
| FEI number | 3003200830 |
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