Z-1857-2025 Class II Ongoing

Recalled by Onkos Surgical, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
June 4, 2025
Initiation Date
September 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units

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.

Distribution Pattern

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