Z-0285-2025 Class II Ongoing
FDA device recall Z-0285-2025 was initiated by Zimmer, Inc. on Sep 17, 2024 and is designated Class II. 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 recall status is ongoing. Affected quantity: 432 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2024
- Initiation Date
- Sep 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0285-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026