Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb S…

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

Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.

• FDA enforcement recordOfficial FDA database entry for Z-1857-2025
• FDA 510(k) clearance · K161520The device's official FDA premarket clearance record
• FDA device classification · KROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3510The 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.