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ELEOS Limb Salvage System CS-09100-03MRecalls & reported problems

Onkos Surgical, Inc. · ELEOS SEGMENTAL STEM, CEMENTED,STRAIGHT, FLUTED, 24MM COLLAR 9MM X 100MM · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278CS0910003M0), received between Aug 19, 2022 and May 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

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.

Most reported problems

Device problems

  • Device Damaged Prior to Receipt by User2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionMay 17, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2023, IT WAS IDENTIFIED THAT THE INNER AND OUTER TRAYS OF THE CEMENTED STRAIGHT SEGMENTAL STEM PACKAGING WERE NO LONGER SEALED. UPON OPENING THE BOX, THIS MALFUNCTION WAS IDENTIFIED AND THE DEVICE WAS NOT USED. THE SURGEON IMPLANTED A DIFFERENT SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16945615 ↗
  • MalfunctionAug 19, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE STERILE BARRIER OF THE PACKAGING OF THE CEMENTED SEGMENTAL STEM WAS COMPROMISED AND NO LONGER SEALED. UPON OPENING THE BOX, THIS MALFUNCTION WAS IDENTIFIED AND THE DEVICE WAS NOT USED. THE SURGEON IMPLANTED A DIFFERENT SIZE CEMENTED SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15262681 ↗

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-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-2425-2025 · Jul 11, 2025 · Open, Classified
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. 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-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-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-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

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices

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Sources and updates

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