ELEOS™ Limb Salvage System 001-03-00021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B27800103000210), received between Sep 24, 2021 and Sep 24, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (3 reports).

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.

• MalfunctionSep 24, 2021Structural Problem; Structural Problem

  DURING A SURGERY WHICH OCCURRED ON (B)(6) 2021 WHICH WAS PERFORMED BY DR. (B)(6), A SURGICAL TECHNICIAN HAD DIFFICULTY REMOVING AN INSTRUMENT (PL-PLANE-03N) FROM AN ELEOS SURGICAL TRAY 21 (001-03-00021). THIS MALFUNCTION WAS REPORTED TO HAVE NOT LED TO A DELAY IN SURGERY OR CAUSE ANY HARM TO THE PATIENT.

  Patient problems: Laceration(s)

  MAUDE report 12526635 ↗
• MalfunctionSep 24, 2021Structural Problem; Structural Problem

  DURING A SURGERY WHICH OCCURRED ON (B)(6) 2021 WHICH WAS PERFORMED BY DR.(B)(6), A SURGICAL TECHNICIAN HAD DIFFICULTY REMOVING AN INSTRUMENT (PL-PLANE-03N) FROM AN ELEOS SURGICAL TRAY 21 (001-03-00021). THIS MALFUNCTION WAS REPORTED TO HAVE NOT LED TO A DELAY IN SURGERY OR CAUSE ANY HARM TO THE PATIENT.

  Patient problems: Laceration(s)

  MAUDE report 12526596 ↗
• MalfunctionSep 24, 2021Structural Problem; Structural Problem

  AN ONKOS REPRESENTATIVE WAS PERFORMING A TRAINING OF SALES REPRESENTATIVES ON THE USE OF INSTRUMENTS IN TRAY 21. WHEN HE ATTEMPTED TO REMOVE PL-PLANE-03N, IT WAS DIFFICULT TO REMOVE AS THE BRACKET WAS TIGHT AROUND THE SHAFT OF THE INSTRUMENT. HE WAS ABLE TO REMOVE THE INSTRUMENT BUT SUSTAINED A LACERATION ON HIS HAND DUE TO STRIKING THE CUTTING SURFACE OF ONE OF THE ADJACENT INSTRUMENTS IN THE TRAY. HE DID NOT SEEK FURTHER MEDICAL CARE AFTER THE INJURY. THERE HAVE CURRENTLY BEEN NO REPORTS OF FURTHER COMPLICATIONS OR LONG-TERM HARMS THAT HAVE OCCURRED FROM THE INJURY. AS THIS ISSUE OCCURRED DURING TRAINING, NO PATIENT WAS AFFECTED BY THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 12526178 ↗