Device recall
Z-2161-2015: Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended…
FDA device recall · Class II · American Medical Systems Innovation Center - Silicon Valley
Key facts
| Recall number (Z-number) | Z-2161-2015 |
|---|---|
| Recall event | 71534 |
| Product | Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision… |
| Product code | GEX |
| Recalling firm | American Medical Systems Innovation Center - Silicon Valley |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2016 |
| 510(k) numbers | K050108 |
| FEI number | 2937094 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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