Recall Z-2424-2025— Onkos Surgical, Inc.

Name: FDA recall Z-2424-2025
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 SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. 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 SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. 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.