Device recall
Z-0162-2020: OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use…
FDA device recall · Class III · Xintec Corp
Key facts
| Recall number (Z-number) | Z-0162-2020 |
|---|---|
| Recall event | 83902 |
| Product | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036 |
| Product code | GEX |
| Recalling firm | Xintec Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K992866 |
| FEI number | 2938889 |
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