GENESYS CrossFT, Hi-Fi CFBC-6502BRecalls & reported problems
Conmed Corporation · GENESYS CROSSFT SUTURE ANCHOR WITH TWO #2 (5 METRIC) HI-FI SUTURES, 6.5 MM · Class 2 · Implant
All models of GENESYS CrossFT, Hi-Fi (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854042493), received between Nov 7, 2025 and Nov 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K101100); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Expiration Date Error; Expiration Date Error
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CFBC-6502B WAS BEING USED ON (B)(6) 2025 AND ¿DR. XXX WAS THE PERFORMING PHYSICIAN. HE SAID HE WAS MADE AWARE OF THE EXPIRATION DURING THE CASE AND ELECTED TO LEAVE IT IMPLANTED, WITH NO ISSUE TO THE PATIENT.¿ THERE WAS NO IMPACT/INJURY OR EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. THE PATIENT IS "RECOVERING WITH NO ADVERSE CONDITIONS." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496689 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K101100. One submission often covers many models, so check the product and lot details in each record.
- Z-3018-2026 · Jul 14, 2026 · Open, ClassifiedCONMED 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
- Z-1619-2013 · Mar 6, 2013 · TerminatedGENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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