FDA Enforcement
Class II
Ongoing
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)
Recall: Z-0285-2025
·
Reported November 13, 2024
Enforcement
- Recall Number
- Z-0285-2025
- Event ID
- 95472
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Zimmer, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2024
- Initiation Date
- September 17, 2024
- Classification Date
- November 1, 2024
- Address
- 1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States
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
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
Code Info
UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092
Distribution
Nationwide
Quantity
432 units