Zimmer recalls Saphena Medical Venapax XL endoscopic vessel harvesting systems due to potential endoscope slot misalignment causing surgical interference. Affected units have specific lot numbers and item codes.
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
Zimmer is recalling Saphena Medical Venapax XL endoscopic vessel harvesting systems because a manufacturing error caused the endoscope slot to be misaligned with the tail piece. This could lead to surgical complications during minimally invasive procedures.
The endoscope slot is misaligned by 0.178 inches due to a manufacturing error where a Gen 5 tail piece was assembled to a Gen 4 device. This misalignment can cause the scope to move further into the plastic sheath, creating an interference fit that may extend surgery time or cause complications.
Surgical teams using the Saphena Medical Venapax XL system for endoscopic vessel harvesting procedures. Patients undergoing arterial bypass surgery with this device are at risk if the system is used without correction.
Check for item number VPX4000 (7273) with UDI codes +M718VPX40001/$$326051543DD6738Q or +M718VPX40001/$$326062143DD8092J. Lot numbers 43DD6738 and 43DD8092 are affected.
Verify the item number and UDI codes to confirm if your device is affected.
A manufacturing error caused a Gen 5 tail piece to be assembled with a Gen 4 device, creating a 0.178-inch misalignment in the endoscope slot.
The misalignment may cause the endoscope to move further into the plastic sheath, leading to an interference fit that could extend surgery time or cause complications.
Check for item number VPX4000 (7273) with UDI codes +M718VPX40001/$$326051543DD6738Q or +M718VPX40001/$$326062143DD8092J and lot numbers 43DD6738 or 43DD8092.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0285-2025 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0285-2025 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
