Class 2 Device Recall Saphena Medical

• Date Initiated by Firm: September 17, 2024
• Date Posted: November 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0285-2025
• Recall Event ID: 95472
• 510(K)Number: K140603
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: 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)
• Code Information: UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer 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
• FDA Determined 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 corporateQuality.PostMarket@zimmerbiomet.com. b. After the RGA number is received, proceed with returning your inventory to the address below: PRIMO MEDICAL GROUP ATTN: ZB Saphena Medical Recall 75 Mill Street Stoughton, MA 02072 c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons 4. If the product has been further distributed, provide your customers with the recall notice and ensure documentation. 5. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. Upon receipt of affected product, Zimmer Biomet will credit your account. 6. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 7. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 432 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI