Device recall
Z-1552-2014: TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1…
FDA device recall · Class II · Tenex Health Inc
Key facts
| Recall number (Z-number) | Z-1552-2014 |
|---|---|
| Recall event | 68074 |
| Product | TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. |
| Product code | LFL |
| Recalling firm | Tenex Health Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2014 |
| 510(k) numbers | K123640 |
| FEI number | 1000135560 |
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