ELEOS™ Limb Salvage System RF-L002E-01MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278RFL002E01M0), received between Jun 9, 2022 and Mar 23, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Loss of Osseointegration

  IT HAS BEEN REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT A PATIENT WITH ELEOS PROXIMAL TIBIAL REPLACEMENT REVISION DATE ON (B)(6) 2026. REPRTED THAT FEMUR WAS REVISED DUE TO PATELLAR TRACKING IN ADDITION TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THIS REPORT CAPTURES ELEOS RESURFACING FEMUR AS SERIOUS INJURY.

  Patient problems: Aseptic loosening

  MAUDE report 24663384 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, RESURFACING FEMUR, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17566524 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH ONKOS DEVICES ON (B)(6) 2022. AN ONKOS CUSTOM ADAPTOR WAS CREATED TO CONNECT TO THE PATIENT'S PREVIOUSLY EXISTING HARDWARE TO THE ONKOS DISTAL FEMUR REPLACEMENT SYSTEM. IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN INFECTION. THE FOLLOWING IMPLANTED DEVICES WERE REMOVED DURING THE REVISION PROCEDURE: CUSTOM COMPRESS ADAPTOR, ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL BASEPLATE TAPERED SCREW, TWO ELEOS MALE-FEMALE MIDSECTIONS, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, AND AN ELEOS TIBIAL BASEPLATE. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY. THIS RECORD CAPTURES THE ELEOS DISTAL FEMUR.

  Patient problems: Unspecified Infection

  MAUDE report 14649357 ↗