Device recall
Z-2171-2015: 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used…
FDA device recall · Class II · American Medical Systems Innovation Center - Silicon Valley
Key facts
| Recall number (Z-number) | Z-2171-2015 |
|---|---|
| Recall event | 71534 |
| Product | 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat… |
| Product code | GEX |
| Recalling firm | American Medical Systems Innovation Center - Silicon Valley |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2016 |
| FEI number | 2937094 |
At a glance
- None 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