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ELEOS™ 25001212ERecalls & reported problems

Onkos Surgical, Inc. · ELEOS™ TIBIAL POLY SPACER 12MM · Class 2 · Implant

Quick summary

This Onkos ELEOS 12mm tibial poly spacer is a plastic insert used in hip and knee replacement joints. The 33 reports mostly describe patients needing revision surgery for infection around the implant, and in one case a loose stem segment; no deaths were reported and all 33 were injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
33
Deaths reported
0
Injuries reported
33
Recalls naming it
0

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI B27825001212E0), received between Aug 31, 2018 and Mar 13, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem32
  • Device Damaged by Another Device1

Patient problems

  • Unspecified Infection18
  • Medical device site infection9
  • Insufficient Information4
  • No Information2
  • Post Operative Wound Infection2
  • Fall1
  • Joint Dislocation1
  • Joint Laxity1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Medical device site infection

    MAUDE report 24592110 ↗
  • InjuryJan 20, 2026Adverse 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 24125506 ↗
  • InjuryJan 15, 2026Adverse 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 UNKNOWN REASONS. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Insufficient Information

    MAUDE report 24089139 ↗
  • InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23981838 ↗
  • InjuryNov 10, 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 SHOWING SIGNS OF LOOSENING ON X-RAY AND ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23515099 ↗
  • InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THERE WAS A REVISION OF AN ELEOS DISTAL FEMUR REPLACEMENT IN AN 57-YEAR-OLD MALE PATIENT DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 22133254 ↗
  • InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2025 DUE TO AN ALLEGED PERI-OPERATIVE INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 21437945 ↗
  • InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION. THE ELEOS CANAL FILLING SEGMENTAL STEM REPORTEDLY LOOSE AND WAS REPLACED DURING REVISION.

    Patient problems: Medical device site infection

    MAUDE report 20788948 ↗
  • InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING THE INVESTIGATION OF A PCR 08232024-1, IT WAS DISCOVERED THAT THE 58-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT THE REVISION WAS REPORTEDLY DUE TO A PERI-OPERATIVE JOINT INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 20305945 ↗
  • InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 58-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION. THE SURGEON, DOCTOR WHITING, PERFORMED THE WASHOUT AT (B)(6) HOSPITAL IN (B)(6).

    Patient problems: Medical device site infection

    MAUDE report 20190243 ↗
  • InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY B. MATSEN, AN ONKOS SALES REPRESENTATIVE, THAT A 16-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A POSSIBLE INFECTION WHICH IS BELIEVED TO BE PREVENTING THE PATIENT'S WOUND FROM HEALING.

    Patient problems: Medical device site infection

    MAUDE report 20025912 ↗
  • InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 76-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR (B)(6), WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES LISTED ABOVE.

    Patient problems: Medical device site infection

    MAUDE report 19724374 ↗
  • InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS REPORT IS A RETROSPECTIVE INVESTIGATION REGARDING TWO OF THE THREE REVISION SURGERIES FOR A SINGLE PATIENT THAT ONKOS WAS PREVIOUSLY UNAWARE. REFER TO SECTION 3.0 FOR ADDITIONAL INFORMATION.DURING THE FIRST REVISION SURGERY ON (B)(6) 2022, THE ORIGINALLY IMPLANTED 8MM TIBIAL POLY SPACER WAS REPLACED WITH A 12MM TIBIAL POLY SPACER. DURING THE SECOND REVISION SURGERY ON (B)(6) 2023, THE 12MM TIBIAL POLY SPACER WAS REPLACED WITH A 20MM TIBIAL POLY SPACER.THE PATIENT RECEIVED AN ELEOS HINGE KNEE REPLACEMENT ON (B)(6) 2022 AT WHICH TIME AN 8MM TIBIAL POLY SPACER WAS IMPLANTED. THE SURGEON FOR THE PRIMARY SURGERY AND THE FIRST TWO SURGICAL REVISIONS WAS PERFORMED BY DOCTOR SIVERHUS. THE THIRD REVISION WAS PERFORMED BY (B)(6).ADDITIONAL PATIENT HISTORY AND SURGICAL DETAILS WERE NOT ABLE TO BE PROVIDED UPON REQUEST TO (B)(6).

    Patient problems: Joint Dislocation; Joint Laxity

    MAUDE report 18845570 ↗
  • InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY B. MATSEN THAT AN ELEOS DFR PATIENT UNDERWENT A REVISION SURGERY. ADDITIONAL DETAILS ARE NOT AVAILABLE AT THIS TIME.

    Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

    MAUDE report 18833005 ↗
  • InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED ON (B)(6) 2023 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY AN ANTIBIOTIC SPACER WAS PLACED AND THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 3, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER THICKNESS 12MM, ELEOS RESURFACING FEMUR SIZE: 3 RIGHT, ELEOS TIBIAL BASEPLATE SIZE: 4, AND ELEOS STEM EXTENSION CEMENTED 14X100MM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

    Patient problems: Insufficient Information; Unspecified Infection

    MAUDE report 17848003 ↗
  • InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: DISTAL FEMUR, MALE-FEMALE MIDSECTION, STEM EXTENSION, RESURFACING PATELLA, TIBIAL BASEPLATE, CEMENTED BOWED SEGMENTAL STEM, AND TIBIAL BASEPLATE TAPERED SCREW. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 17560965 ↗
  • InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND EXTENSOR MECHANISM DISRUPTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: CEMENTED SEGMENTAL STEM, TWO MALE FEMAL MIDSECTIONS, DISTAL FEMUR, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE DATE OF THE PATIENT'S INDEX ELEOS SURGERY IS UNKNOWN AND THE IMPLANTS PLACED DURING THIS PROCEDURE ARE UNKNOWN. THEREFORE, IT IS UNKNOWN IF THERE WERE ADDITIONAL IMPLANTS AT THE TIME OF THIS PATIENT'S ALLEGED INFECTION AND EXTENSOR MECHANISM DISRUPTION. ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Patient problems: Insufficient Information; Unspecified Infection

    MAUDE report 17025291 ↗
  • InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

    Patient problems: Insufficient Information; Unspecified Infection

    MAUDE report 16028307 ↗
  • InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED SEGMENTAL STEM, CANAL-FILLING STEM EXTENSION, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 14690892 ↗
  • InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT UNDERWENT A POLYSWAP PROCEDURE. THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR, AXIAL PIN, TIBIAL HINGE COMPONENT, SEGMENTAL STEM - CEMENTED, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, TWO TIBIAL AUGMENTS, STEM EXTENSION - CEMENTED, AND A POLY SPACER. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO REVISION SURGERY. THIS RECORD CAPTURES THE ELEOS TIBIAL POLYSPACER.

    Patient problems: Unspecified Infection

    MAUDE report 14120788 ↗
  • InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, TIBIAL HINGE COMPONENT, CANAL-FILLING STEM, TIBIAL BASEPLATE, AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 13447162 ↗
  • InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED WOUND INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED STEM EXTENSION, TIBIAL BASEPLATE, AND CEMENTED SEGMENTAL STEM. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

    Patient problems: Post Operative Wound Infection; Unspecified Infection

    MAUDE report 12870525 ↗
  • InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. THE FOLLOWING PART WERE REMOVED AND REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: TIBIAL BASEPLATE, DISTAL FEMUR, STEM EXTENSION, COLLAR, COLLAR LOCKING RING, AND CEMENTED STEM . THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED INCISION AND DRAINAGE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Patient problems: Unspecified Infection

    MAUDE report 12523231 ↗
  • InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, ELEOS TIBIAL POLY SPACER, ELEOS SEGMENTAL STEM, AND ELEOS TIBIAL HINGE COMPONENT. ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIED THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL ELEOS SURGERY: TIBIAL BASEPLATE, 2 TIBIAL BLOCK AUGMENTS, STEM EXTENSION, AND MODULAR TIBIAL BASE STEM CAP. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 12454623 ↗
  • InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. THE FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: 2 TIBIAL BLOCK AUGMENTS, RESURFACING FEMUR, CEMENTED STEM EXTENSION (18MM X 100MM), CEMENTED STEM EXTENSION (16MM X 65MM), AND TIBIAL BASEPLATE. THE SURGEON PERFORMED A WASHOUT AND ADMINISTERED ANTIBIOTICS. NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Patient problems: Unspecified Infection

    MAUDE report 12388381 ↗

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-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-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-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

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.