Recall Z-3018-2026 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
ConMed Corporation
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
| Date | Aug 26, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. |
| Root 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. Revi |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 Conmed Linvatec, Aug 26, 2010 |