Infinity KFB035Recalls & reported problems
Conmed Corporation · INFINITY FEMORAL ADJUSTABLE LOOP BUTTON · Class 2 · Implant
All models of Infinity (12)
Data updated Oct 16, 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 20845854649067), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionMar 2, 2026Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KFB035 INFINITY FEMORAL ADJUSTABLE LOOP BUTTON DEVICE WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿DURING A SURGICAL PROCEDURE ONE WAS FOUND DAMAGED.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF A GRASPER AND SUTURE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "GOOD". THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482329 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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