Device recall
Z-0070-04: LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling…
FDA device recall · Class II · Misonix, Inc
Key facts
| Recall number (Z-number) | Z-0070-04 |
|---|---|
| Recall event | 27501 |
| Product | LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September… |
| Product code | LFL |
| Recalling firm | Misonix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2005 |
| 510(k) numbers | K933559 |
| FEI number | 2435119 |
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