Arthrex® AR-601-FTLERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867037151), received between Dec 28, 2020 and Dec 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 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.

• InjuryDec 28, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A (B)(6) 2020 MEDIAL UKA PROCEDURE THE SURGEON WAS REMOVING THE ARTHREX AR-601-FTLE, IBALANCE UKA TRIAL FEMORAL IMPLANT (LOT UNKNOWN). THE SURGEON WAS USING A SMALL CURVED OSTEOTOME TO REMOVE THE TRIAL IMPLANT AND AS HE GENTLY TAPPED THE TOPSIDE OF THE TRIAL TO DISENGAGE IT FROM THE DISTAL FEMUR, IT CAME OFF AT AN ANGLE IN WHICH THE INSIDE PORTION OF THE MEDIAL CONDYLE CAME OFF WITH IT. THE AR-601-FTLE TRIAL IMPLANT DID NOT BREAK AND THE INSTRUMENT THE SURGEON WAS USING TO REMOVE THE TRIAL ALSO DID NOT BREAK. THE SURGEON DID COMPLETE THE PROCEDURE AS INTENDED AFTER EVALUATING THAT THERE WAS ENOUGH DISTAL FEMUR LEFT FOR DECENT FIXATION. HE FINISHED THE PROCEDURE CEMENTING THE PERMANENT FEMORAL COMPONENT AS INTENDED. SINCE THERE WAS NO ISSUE WITH THE ARTHREX AR-601-FTLE ITSELF THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 11075935 ↗