Device recall
Z-0285-2025: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0285-2025 |
|---|---|
| Recall event | 95472 |
| Product | Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273) |
| Product code | GEI |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140603 |
| FEI number | 1000220733 |
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