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ELEOS™ 2500SP12ERecalls & reported problems

Onkos Surgical, Inc. · ELEOS™ SEGMENTAL STEM, CANAL FILLING STRAIGHT, SPLINED, FULL PLASMA, 25MM COLLAR 12MM X 120MM · Class 2 · Implant

Data updated Oct 13, 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 B2782500SP12E0), received between Dec 1, 2020 and Nov 16, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Fracture1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Bone Fracture(s)1
  • Failure of Implant1
  • Fall1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE PATIENT'S FELL AND FRACTURED THEIR FEMUR AROUND THE FEMORAL STEM. THE PATIENT HAD A REVISION SURGERY SCHEDULED ON (B)(6) 2021 BUT IT WAS CANCELLED DUE TO THE PATIENT'S POTASSIUM LEVELS BEING TOO HIGH. THE REVISION SURGERY WAS RESCHEDULED TO (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, SEGMENTAL STEM, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

    Patient problems: Bone Fracture(s); Fall; Insufficient Information

    MAUDE report 12823939 ↗
  • InjuryDec 1, 2020Fracture; Fracture

    PATIENT UNDERWENT A REVISION SURGERY DUE TO THEIR FEMORAL STEM FRACTURING.

    Patient problems: Failure of Implant

    MAUDE report 10927959 ↗

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-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-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-1857-2025 · Sep 22, 2024 · Open, Classified
    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
  • 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-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-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-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-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-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

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

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

Sources and updates

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