Reported Nov 13, 2024 · Ongoing
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- 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 NumberVPX4000 (7273)
- Lot codes and dates
- UDI
+M718VPX40001/$$326051543DD6738Q+M718VPX4001/$$326062143DD8092J
- Lot Numbers
43DD673843DD8092
- UDI
- Amount recalled
- 432 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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