Recall Z-0285-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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 undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
| Date | Nov 1, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Component change control |
| Action | Zimmer Biomet, in partnership with Saphena Medical, Inc issued Urgent Medical Device Recall Letter- Lot Specific on 9/17/24 via Fed'X. Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory. 3. Return all affected product from your facility. a. Request a Return Goods Authorization (RGA) number by emailing the completed Attachment 1 Certificate of Acknowledgement form to corpor |
| Quantity | 432 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140603 | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM Saphena Medical, Inc., Jul 31, 2014 |