ELEOS™ 25002100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI B27825002100E0), received between Jun 18, 2018 and Apr 17, 2025 — classified as 4 deaths, 75 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21858219 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 61-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Medical device site infection

  MAUDE report 21038376 ↗
• 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 84-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20789036 ↗
• InjuryJun 20, 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 74-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 19577032 ↗
• InjuryMay 9, 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 74-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE 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.

  Patient problems: Medical device site infection

  MAUDE report 19280193 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY WILL MCDONALD, AN ONKOS DISTRIBUTOR, THAT A 32-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED JOINT INFECTION ON (B)(4) 2024. THE PRIMARY SURGERY TOOK PLACE ON (B)(4) 2019 WHEN THE PATIENT WAS 28 YEARS OLD. THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND IDENTIFYING LOT NUMBERS WERE NOT PROVIDED FOR SEVERAL OF THE EXPLANTED DEVICES. NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM WILL MCDONALD WERE MADE VIA PHONE AND EMAIL; NO ADDITIONAL INFORMATION WAS PROVIDED. ALL OTHER ELEOS DEVICES IMPLANTED DURING THE PRIMARY SURGERY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 18817880 ↗
• InjuryMar 24, 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. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAINED IMPLANTED DURING THE REVISION SURGERY: SEGMENTAL STEM, TIBIAL BASEPLATE, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16616078 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN AND ELEOS DISTAL FEMUR. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CANAL-FILLING STEM EXTENSION, TIBIAL BASEPLATE, MALE-FEMALE MIDSECTIONS, MALE-MALE MIDSECTION, AND PROXIMAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16482882 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2023 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16297122 ↗
• InjuryNov 23, 2022Fracture; Fracture

  A PATIENT REPORTED THEIR KNEE FEELING LOOSE. UPON IMAGING, IT WAS IDENTIFIED THAT THE POST OF THE PATIENT'S ELEOS TIBIAL HINGE COMPONENT HAD BROKEN OFF. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE AND REPLACE THE PATIENT'S ELEOS TIBIAL HINGE COMPONENT ON (B)(6) 2022. DURING THE REVISION PROCEDURE, THE SURGEON ALSO REVISED THE PATIENT'S DISTAL FEMUR AXIAL PIN AND POLY SPACER; HOWEVER, THERE WERE NO ALLEGED ISSUES REPORTED WITH THESE TWO DEVICES. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY AS THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853658 ↗
• InjuryMay 19, 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 19 APRIL 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: ELEOS TIBIAL POLY SPACER 8 MM, ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 4, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS STEM EXTENSION CANAL FILLING SIZE: 14 MM X 140 MM STRAIGHT SPLINED SLOTTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5 MM, ELEOS TIBIAL BASEPLATE SIZE: 2, ELEOS STEM EXTENSION CEMENTED SIZE: 12 MM X 100 MM STRAIGHT FLUTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5 MM, AND ELEOS RESURFACING FEMUR SIZE 4 LEFT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14438629 ↗
• InjuryApr 27, 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 TO WASHOUT THEIR PROXIMAL FEMORAL REPLACEMENT SYSTEM. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY TO WASHOUT THEIR DISTAL FEMORAL REPLACEMENT SYSTEM AND REVISE THE TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY WHERE ALL IMPLANTS WERE REVISED. THE FOLLOWING IMPLANTS WERE REVISED: MALE-MALE MIDSECTION, MALE-FEMALE MIDSECTION, POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, PROXIMAL FEMUR, AND DISTAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 14228980 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO THEIR STEM EXTENSION LOOSENING AND A FLEXION CONTRACTURE. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, RESURFACING FEMUR, RESURFACING FEMUR AXIAL PIN, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Contracture

  MAUDE report 13675126 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2022 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 2. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13586292 ↗
• InjuryJan 14, 2022Adverse 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) 2020 DUE TO AN ALLEGED INFECTION. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS WERE IMPLANTED AT THE TIME AND WERE NOT REVISED DURING THIS REVISION SURGERY: SEGMENTAL STEM, STEM EXTENSION, TIBIAL BASEPLATE AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13261639 ↗
• InjuryDec 28, 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 INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, PROXIMAL TIBIA, CEMENTED BOWED STEM, CEMENTED STRAIGHT STEM, POLY SPACER, DISTAL FEMUR AXIAL PIN, AND TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13095995 ↗
• InjuryDec 17, 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 AND A LOOSE CEMENTED SEGMENTAL STEM. THE SURGEON PERFORMED INCISION & DRAINAGE. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, AND CEMENTED SEGMENTAL STEM. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13029761 ↗
• InjuryDec 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE POST BROKE OFF OF THE PATIENT'S TIBIAL HINGE COMPONENT. THE SURGEON PERFORMED A REVISION SURGERY ON THIS PATIENT ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13014833 ↗
• InjuryNov 18, 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 INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, 50MM MALE-FEMALE MIDSECTION, AND 110MM MALE-FEMALE MIDSECTION. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED BOWED STEM, TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12840316 ↗
• InjuryNov 15, 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 ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, AND TIBIAL HINGE COMPONENT. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM, MALE-FEMALE MIDSECTION, DISTAL FEMUR, TIBIAL BASEPLATE, (2) TIBIAL BLOCK AUGMENTS, AND CANAL-FILLING STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12816950 ↗
• InjuryOct 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO THE POST BREAKING OFF OF THE TIBIAL HINGE COMPONENT. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12619122 ↗
• InjuryJul 1, 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 PATIENT DEVELOPED AN ALLEGED INFECTION WITH SMITH & NEPHEW IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2019 FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A FIRST STAGE REVISION SURGERY ON (B)(6) 2019 WHERE THE FOLLOWING ELEOS PARTS WERE IMPLANTED: TIBIAL HINGE COMPONENT WITH ROTATIONAL STOP, TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, DISTAL FEMUR AXIAL PIN, SEGMENTAL STEM, AND TIBIAL POLY SPACER. THE SECOND STAGE REVISION SURGERY TOOK PLACE ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS COMPONENTS WERE REMOVED AND REPLACED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. A WASHOUT WAS PERFORMED AND ADDITIONAL ANTIBIOTICS WERE INSERTED. THE FOLLOWING ELEOS COMPONENTS ARE STILL IMPLANTED: TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12099600 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY, THE SURGEON EXPLANTED THE FOLLOWING COMPONENTS: A TIBIAL HINGE COMPONENT, A TIBIAL POLY SPACER, AND A DISTAL FEMUR AXIAL PIN. THE FOLLOWING IMPLANTS WERE ALSO IMPLANTED IN THE PATIENT AT THE TIME OF THE INFECTION AND REVISION SURGERY: A SEGMENTAL STEM, A TIBIAL BASEPLATE, A DISTAL FEMUR COMPONENT, AND A STEM EXTENSION. THE SURGEON PERFORMED A WASHOUT OF THE AREA AND REVISED ALL OF THE IMPLANTS THAT CONTAINED POLY COMPONENTS. NO FUTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Unspecified Infection

  MAUDE report 11966896 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO AN ALLEGED INFECTION. DURING THE REVISION, THE SURGEON EXPLANTED THE FOLLOWING COMPONENTS THAT CONTAINED POLY: THE TIBIAL POLY SPACER, THE DISTAL FEMUR AXIAL PIN, AND THE TIBIAL BASEPLATE. THE SURGEON ALSO PERFORMED A WASHOUT OF THE INFECTED AREA.

  Patient problems: Unspecified Infection

  MAUDE report 11870517 ↗
• InjuryMay 6, 2021Insufficient Device Problem Information

  A PATIENT WAS REPORTED TO HAVE UNDERGONE A REVISION SURGERY WHERE A WASHOUT WAS PERFORMED. THE REASON FOR THE WASHOUT IS CURRENTLY UNKNOWN. A POSTBILLING FORM FROM THE REVISION SURGERY FOUND THAT A NEW TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, AND A DISTAL FEMUR AXIAL PIN WERE PLACED. THIS WAS MOST LIKELY THE RESULT OF REPLACING EXPLANTED IMPLANTS. IT IS UNKNOWN AT THIS TIME WHETHER A FAILURE OF THESE IMPLANTS OCCURED.

  Patient problems: Insufficient Information

  MAUDE report 11786328 ↗

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-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-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
• 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