ELEOS™ 26012805ERecalls & reported problems

Onkos Surgical, Inc. · FEMORAL HEAD, 28MM TAPER, +10.5MM 28MM, +10.5MM · Class 2 · Implant

All models of ELEOS (127)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B27826012805E0), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 injury.

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Medical device site infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN ELEOS PROXIMAL FEMURE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS FEMORAL HEAD. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION SURGERY.
Patient problems: Medical device site infection
MAUDE report 22737198 ↗

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-2423-2025 · Jul 11, 2025 · Open, Classified
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. 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-1857-2025 · Sep 22, 2024 · Open, Classified
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
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-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-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-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-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
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-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

Device details

UDI-DI	`B27826012805E0`
Brand	ELEOS™
Model	26012805E
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	Apr 6, 2020

Device type (GMDN): Metallic femoral head prosthesis

An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

NA 1365-51-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
753 reports
NA 1365-50-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
412 reports
ARTICUL/EZE 1365-21-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
1 recall280 reports
ARTICUL/EZE 1365-11-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
1 death262 reports
LFIT 6260-9-236
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
256 reports
PINNACLE GRIPTION 1217-32-052
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
2 deaths239 reports
ELEOS™ 25002111E
Onkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
3 deaths230 reports
Novation 130-36-52
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
2 recalls124 reports

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

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 16, 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