ELEOS Limb Salvage System FB-19152-03MRecalls & reported problems

Onkos Surgical, Inc. · ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 19MM X 152MM · Class 2 · Implant

All models of ELEOS Limb Salvage System (48)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278FB1915203M0), received between May 20, 2022 and Nov 29, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K161520); they may or may not involve this specific model.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1
Migration1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT UNDERWENT DISTAL FEMUR REVISION. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: Insufficient Information
MAUDE report 18234482 ↗
InjuryMay 20, 2022Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO AN ELEOS CANAL FILLING STEM WHICH LOOSENED OVER TIME. THE PATIENT'S INDEX SURGERY WAS ON (B)(6) 2019, WHERE THE PATIENT WAS IMPLANTED WITH THE CANAL FILLING STEM, A MALE-FEMALE MIDSECTION, AND A CUSTOM ADAPTOR. THE PATIENT WAS REVISED ON (B)(6) 2022 TO REMOVE AND REPLACE THE CANAL FILLING STEM AND MALE-FEMALE MIDSECTION. THE CUSTOM ADAPTOR WAS LEFT IMPLANTED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. NO ALLEGED ISSUES OCCURED WITH THE MALE-FEMALE MIDSECTION AND THE CUSTOM ADAPTOR; THEREFORE, THESE DEVICES ARE CONCOMITANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14453887 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161520. One submission often covers many models, so check the product and lot details in each record.

Z-2425-2025 · Jul 11, 2025 · Open, Classified
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Z-2424-2025 · Jul 11, 2025 · Open, Classified
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Z-2423-2025 · Jul 11, 2025 · Open, Classified
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Z-1857-2025 · Sep 22, 2024 · Open, Classified
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Z-1879-2025 · Sep 1, 2023 · Open, Classified
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M,
Z-1881-2025 · Sep 1, 2023 · Open, Classified
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03
Z-1882-2025 · Sep 1, 2023 · Open, Classified
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, F
Z-1884-2025 · Sep 1, 2023 · Open, Classified
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model
Z-2647-2017 · May 23, 2017 · Terminated
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Z-2646-2017 · May 23, 2017 · Terminated
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Z-2648-2017 · May 23, 2017 · Terminated
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E

Device details

UDI-DI	`B278FB1915203M0`
Brand	ELEOS Limb Salvage System
Model	FB-19152-03M
Company	Onkos Surgical, Inc.
Product code	JDI · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Class	Class 2
FDA submission	K161520
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2022

Device type (GMDN): Body femoral/tibial extension stem, uncoated

A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.

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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.

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