ELEOS™ K0002008ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B278K0002008E0), received between Jul 8, 2024 and Jul 8, 2024 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 8, 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 63-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT IN THE RIGHT-SIDE KNEE UNDERWENT A REVISION SURGERY ON (B)(6) 2024 DUE TO A FRACTURE OF THE LATERAL CONDYLE WHICH WAS SUSTAINED WHEN THE PATIENT REPORTEDLY FELL DOWN THE STAIRS. THE FEMORAL STEM WAS UNABLE TO BE EXTRACTED BY DOCTOR SALAAM DUE TO THREAD DAMAGE ON THE SLAP HAMMER INSTRUMENT. THE PATIENT'S DISTAL FEMUR WAS THEREFORE RESECTED MORE THAN INITIALLY PLANNED TO REMOVE THE INCARCERATED STEM; THIS ISSUE RESULTED IN A 1-HOUR EXTENSION OF THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19693569 ↗

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-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-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-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-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