Onkos Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1817-2025)

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 COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

Product Classification:

Class II

Date Initiated: December 22, 2023

Date Posted: June 4, 2025

Recall Number: Z-1817-2025

Event ID: 96781

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.

Status: Ongoing

Product Quantity: 23 units

Code Information:

Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated