Onkos Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1857-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Product Classification:

Class II

Date Initiated: September 22, 2024

Date Posted: June 4, 2025

Recall Number: Z-1857-2025

Event ID: 96780

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.

Status: Ongoing

Product Quantity: 24 units

Code Information:

Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

Voluntary or Mandated:

Voluntary: Firm initiated