GENESYS CrossFT, Hi-Fi CFBC-5502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854026783), received between Nov 25, 2024 and Nov 25, 2024 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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, Classified
  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
• Z-1619-2013 · Mar 6, 2013 · Terminated
  GENESYS 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