Zimmer, Inc.: Venapax XL Vessel Harvesting System Recalled for Assembly Error

Agency Publication Date: November 1, 2024

Summary

Zimmer, Inc. is recalling 432 units of the Saphena Medical Venapax XL Endoscopic Vessel Harvesting System because of a manufacturing defect where an incorrect part was installed during assembly. Specifically, a Generation 5 tail piece was attached to a Generation 4 device, creating a measurement discrepancy that allows the endoscope to move too far into its plastic sheath. This surgical device is primarily used for harvesting vessels in patients undergoing arterial bypass surgery. Consumers should contact their healthcare provider or the manufacturer regarding this defect.

Risk

The assembly error results in an interference fit at the device cone, which can cause the endoscope to become stuck or misaligned. This failure may lead to unexpected delays and extensions in surgery time while the medical team addresses the equipment issue.

What You Should Do

Identify if you have the Saphena Medical Venapax XL Endoscopic Vessel Harvesting System (Item Number VPX4000) by checking the packaging for Lot Numbers 43DD6738 or 43DD8092.
Verify the Unique Device Identifier (UDI) on the product label: +M718VPX40001/$$326051543DD6738Q or +M718VPX4001/$$326062143DD8092J.
If you are a healthcare provider, immediately quarantine any affected units and stop using the specific lots identified in this recall.
Contact Zimmer, Inc. or your local representative to arrange for the return of the affected products and to receive further instructions on replacements.
Contact your healthcare provider if you have concerns regarding a procedure where this device may have been used.
For additional information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Medical Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System

Model / REF:

VPX4000

7273

Lot Numbers:

43DD6738

43DD8092

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95472

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Zimmer, Inc.; Hospital supply chains

Manufactured In: United States

Units Affected: 432 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the Saphena Medical Venapax XL Endoscopic Vessel Harvesting System (Item Number VPX4000) by checking the packaging for Lot Numbers 43DD6738 or 43DD8092.

Verify the Unique Device Identifier (UDI) on the product label: +M718VPX40001/$$326051543DD6738Q or +M718VPX4001/$$326062143DD8092J.

If you are a healthcare provider, immediately quarantine any affected units and stop using the specific lots identified in this recall.

Contact Zimmer, Inc. or your local representative to arrange for the return of the affected products and to receive further instructions on replacements.

Contact your healthcare provider if you have concerns regarding a procedure where this device may have been used.

For additional information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.