Recall Z-2423-2025— Onkos Surgical, Inc.

Name: FDA recall Z-2423-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Class II · Ongoing

Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2025-07-11. It names 2 FDA 510(k) clearances: K203588, K161520. Product: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.. Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation..

Recalling firm: Onkos Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-11
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K203588 — ELEOS Limb Salvage SystemOnkos Surgical·cleared 2021-02-05
K161520 — ELEOS Limb Salvage SystemOnkos Surgical, Inc.·cleared 2016-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.