ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of L...
FDA Recall #Z-1818-2025 — Class II — December 22, 2023
Product Description
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
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.
Recalling Firm
Onkos Surgical, Inc. — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
23 units
Distribution
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Code Information
Model Number: HC-15120-03M. UDI-DI: B278HC1512003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated