Class II

Medical Device Recall: ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

Onkos Surgical, Inc. · December 22, 2023

Reason for Recall

Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

Distribution

US Nationwide distribution in the states of California, Kentucky, and Wisconsin.

States Affected

NATIONWIDE

Quantity Affected

23 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1818-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Onkos Surgical, Inc. Medical Device Recall: ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip. | SafeCheck