GENESYS CrossFT, Hi-FiRecalls & reported problems across all models

We found 4 models of GENESYS CrossFT, Hi-Fi by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2022 and Mar 4, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GENESYS CrossFT, Hi-Fi recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 14, 2026Open, Classified

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

   Z-3018-2026 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported GENESYS CrossFT, Hi-Fi problems

GENESYS CrossFT, Hi-Fi models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GENESYS CrossFT, Hi-Fi CFBC-5502B

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 recall1 report
• GENESYS CrossFT, Hi-Fi CFBC-5502

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 report
• GENESYS CrossFT, Hi-Fi CFBC-6502B

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 report
• GENESYS CrossFT, Hi-Fi CFBC-5503B

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 report

Recent GENESYS CrossFT, Hi-Fi adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CFBC-5503B, SUTURE ANCHOR WITH THREE #2 (5 METRIC) HI-FI SUTURES,5.5 MM, WAS BEING USED DURING A ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿INSERTER BROKE, THE TIP CAME DETACHED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DELAY. FURTHER ASSESSMENT FOUND THE INSERTER BROKE DURING USE, A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED USING AN ARTHROSCOPIC GRASPER. 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 24511313 ↗
• 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 ↗
• MalfunctionNov 25, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, CFBC-5502, SUTURE ANCHOR WITH TWO #2 (5 METRIC) HI-FI SUTURES,5.5 MM, WAS BEING USED DURING A RC REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿SO, AFTER MAKING PILOT HOLE TO INSERT THE ANCHOR, FIRST ANCHOR AFTER SCREWING GOT OUT FROM THE PILOT ANCHOR ALONG WITH THE SUTURE AND SECOND ONE BROKE DOWN UPON INSERTION.¿ FURTHER ASSESSMENT QUESTIONING FOUND FROM THE REPORTER, ¿YES, DEVICE GOT BROKE DURING THE SURGERY, AND FRAGMENT ALSO FELL OFF AT THE SURGICAL SITE BUT IT WAS REMOVED COMPLETELY WITH THE HELP OF GRAPSER WITH OUT ANY HARM. SURGERY WAS COMPLETED USING SIRONIX TITANIUM METAL ANCHOR AT THE SAME PLACE. NO INTERVENTION REQUIRED, PATIENT WAS TREATED AS PER SURGERY PROCEDURE AND DISCHARGED AS USUAL. NO PROLONGATION OF STAY DUE TO THIS.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 20770569 ↗
• MalfunctionApr 21, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CFBC-5502B, 5.5MM GENESYS CROSSFT SUTURE ANCHOR, WAS BEING USED ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED THAT THE ¿ANCHOR BROKE INTO MULTIPLE PIECES WHEN THE SURGEON TRIED IMPLANTING IT INTO PATIENT'S SHOULDER.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH A 2 MINUTE DELAY. FURTHER ASSESSMENT FOUND THAT DR. (B)(6) WAS THE SURGEON, THE DEVICE WAS RETRIEVED, THE INTERVENTION WAS OPENING A NEW ANCHOR, THE PATIENT WASN'T INJURED, THE PATIENT WASN'T EFFECTED, THERE WAS NO EXTENDED STAY NEEDED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171976 ↗

Other Conmed Corporation products

• AIRSEAL15 models · 236 reports · 11 recalls
• VCARE4 models · 285 reports
• PlumePen8 models · 132 reports
• CONMED GOLDLINE10 models · 112 reports
• ANCHOR TISSUE RETRIEVAL SYSTEM8 models · 92 reports
• UltraClean8 models · 84 reports
• UNIVERSAL PLUS9 models · 68 reports
• Y-KNOT14 models · 65 reports