Class 2 Device Recall CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver

• Date Initiated by Firm: July 14, 2026
• Date Posted: August 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3018-2026
• Recall Event ID: 99498
• 510(K)Number: K101100
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
• Code Information: UDI:10845854042472, Lot number 1513167
• FEI Number: 3001451571
• Recalling Firm/ Manufacturer: ConMed Corporation; 525 French Rd; Utica NY 13502-5945
• For Additional Information Contact: Brent Lalomia; 269-377-2187
• Manufacturer Reason for Recall: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
• FDA Determined Cause: Labeling design
• Action: On July 14, 2026, Conmed Corporation issued an Urgent Medical Device Correction to affected consignees via email: Conmed Corporation asked consignees to take the following actions: 1. Replace the Patient Implant Card with the corrected Patient Implant Card included with this notification. 2.Retain the corrected Patient Implant Card for your records and discard the incorrect PIC to ensure accurate device traceability and recordkeeping. 3. If you have provided these devices to other facilities or distributors, or you are a distributor, please forward this information as appropriate. 4. Review your inventory for any of the devices listed in Table 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. 5. Devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 6. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com 7. For devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 8. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com
• Quantity in Commerce: 2 units
• Distribution: US Nationwide distribution in the state of TX.
• 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 = MAI