Onkos Surgical, Inc. recalls ELEOS COLLAR STEM

Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

ONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs.

• FDA enforcement recordOfficial FDA database entry for Z-1817-2025
• FDA 510(k) clearance · K203815The 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.