ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
FDA Recall #Z-1857-2025 — Class II — September 22, 2024
Product Description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Reason for Recall
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Recalling Firm
Onkos Surgical, Inc. — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 units
Distribution
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Code Information
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated