Device recall
Z-2585-2011: Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT…
FDA device recall · Class II · Integra Limited
Key facts
| Recall number (Z-number) | Z-2585-2011 |
|---|---|
| Recall event | 58837 |
| Product | Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery… |
| Product code | LFL |
| Recalling firm | Integra Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2014 |
| 510(k) numbers | K081459 |
| FEI number | 3001700044 |
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