Home / Recalls / Zimmer, Inc. / Z-0285-2025

Z-0285-2025 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
November 13, 2024
Initiation Date
September 17, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
432 units

Product Description

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 Pattern

Nationwide

Code Information

UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092

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