Device recall
Z-0579-2019: Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve…
FDA device recall · Class II · Leoni Fiber Optics GmbH
Key facts
| Recall number (Z-number) | Z-0579-2019 |
|---|---|
| Recall event | 81519 |
| Product | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any… |
| Product code | GEX |
| Recalling firm | Leoni Fiber Optics GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2020 |
| 510(k) numbers | K050738 |
| FEI number | 3005128587 |
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