# FDA recall Z-0285-2025

> **Zimmer, Inc.** · Class II · device recall initiated 2024-09-17.

## 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)

## Reason for recall

A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0285-2025
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-17
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2025

## Citation

> AI Analytics. FDA recall Z-0285-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0285-2025. Source: US FDA. Licensed CC0.

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