Zimmer, Inc.: 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 underg

Hazard

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

Details from the source

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: Nationwide Quantity: 432 units Lot/code info: UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.