Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

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

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

An email dated 7/11/25 was sent to consignees notifying them of this recall. Distributors and sales personnel are to segregate and quarantine affected devices immediately and return a completed Product and Distribution Information Table to mdufner@onkossurgical.com. Affected devices are to be returned within two business days to Onkos Surgical. Consignees with any questions are to contact Matt Dufner with any questions at 267-566-4560 or mdufner@onkossurgical.com. An email dated 8/5/25 was sent to surgical consignees notifying them of this recall. Hospitals are to remove affected devices from their facilities, forwarding any affected devices remaining in their possession to their Onkos Sales Representative. Onkos Surgical is in the process of determining the root cause of this recall issue and is performing additional testing on returning devices. Consignees with any questions are to contact Matt Dufner at 267-566-4560 or mdufner@onkossurgical.com.

• FDA enforcement recordOfficial FDA database entry for Z-2425-2025
• FDA 510(k) clearance · K161520The device's official FDA premarket clearance record
• FDA 510(k) clearance · K203588The device's official FDA premarket clearance record
• FDA device classification · JDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Onkos Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.