ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-070MFRecalls & reported problems
Onkos Surgical, Inc. · ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 70MM · Class 2 · Implant
All models of ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278AMMS070MF0), received between Apr 4, 2025 and Dec 16, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Use of Device Problem1
Patient problems
- Medical device site infection2
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS NANOCEPT MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23821982 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS NANOCEPT MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23526974 ↗InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.
Patient problems: Medical device site infection
MAUDE report 22039932 ↗InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.
Patient problems: Medical device site infection
MAUDE report 22039930 ↗InjuryApr 4, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT DURING A NON-ONKOS REVISION TO IMPLANT AN ELEOS TOTAL FEMUR REPLACEMENT, THE SURGEON HAD INITIALLY SELECTED THE APPROPRIATE CONSTRUCT LENGTH WITH IMPLANT TRIALS BUT SUBSEQUENTLY INCREASED THE TOTAL CONSTRUCT LENGTH BY 2CM INTRAOPERATIVELY. THIS SWITCH WAS MADE BY THE SURGEON AGAINST THE RECOMMENDATIONS OF THE ONKOS SALES REPRESENTATIVE. THERE IS NO ALLEGED FAILURE OF THE REVISED NANOCEPT MIDSECTION TO MEET ANY OF ITS PRODUCT SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773374 ↗
Other Limb And Joint Salvage Device With Coating For Bacteria Reduction devices
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-040MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction25 reports
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-060MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction19 reports
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-050MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction14 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page