Device recall
Z-1841-2014: Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical…
FDA device recall · Class II · SeaSpine Inc
Key facts
| Recall number (Z-number) | Z-1841-2014 |
|---|---|
| Recall event | 68362 |
| Product | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or… |
| Product code | NKB |
| Recalling firm | SeaSpine Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2014 |
| 510(k) numbers | K043232 |
| FEI number | 3003790069 |
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