Zimmer, Inc. recalls Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access f…

Recall date

September 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0285-2025

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)