Recall Z-3018-2026— ConMed Corporation

Name: FDA recall Z-3018-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-14

Class II · Ongoing

Class II FDA medical device recall by ConMed Corporation, initiated 2026-07-14. It names one FDA 510(k) clearance: K101100. 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. Reason: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability..

Recalling firm: ConMed Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-07-14
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec·cleared 2010-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Data sourced from openFDA. This site is unofficial and independent of the FDA.