Infinity KFL100Recalls & reported problems
Conmed Corporation · INFINITY ADJUSTABLE FREE LOOP · 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 20845854649081), received between Nov 8, 2023 and Nov 8, 2023 — 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.
MalfunctionNov 8, 2023Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE KFL100, KPS ADJUSTABLE FREE LOOP WAS BEING USED DURING AN ACL & PCL WITH MENISCUS REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BROKE DURING THE SURGERY TIMING.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO 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 18093083 ↗
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- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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