Onkos Surgical, Inc.: Device Recall

Recall #Z-2425-2025 · 07/11/2025

Class II: Risk

Recall Details

Recall Number: Z-2425-2025
Classification: Class II
Product Type: Device
Recalling Firm: Onkos Surgical, Inc.
Status: Ongoing
Date Initiated: 07/11/2025
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 554 units

Reason for Recall

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Product Description

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

Distribution Pattern

US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.

Other Recalls by Onkos Surgical, Inc.

Class II: Risk 07/11/2025

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II: Risk 07/11/2025

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II: Risk 05/20/2025

Required inspections were not performed on finished product prior to release and distribution.
Class II: Risk 09/22/2024

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

View all recalls by Onkos Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.