Onkos Surgical recalls ELEOS Collar Stem (HC-15120-03M) due to mislabeling as 13mm when it's 15mm. This could lead to improper implant fitting during surgery. Affected units have specific model and serial numbers.
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 is recalling ELEOS Collar Stems (model HC-15120-03M) because they were mislabeled as 13mm when they're actually 15mm. This mislabeling could cause improper implant fitting during surgery, potentially leading to complications. Read more at govinfonow.com/recall/56484-onkos-surgical-eleos-collar-stem-recall-mislabeling-risk.
“Onkos Surgical ELEOS Collar Stem Recall: Mislabeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56484-onkos-surgical-eleos-collar-stem-recall-mislabeling-risk. Based on FDA recall #Z-1818-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2025%22&limit=1).
The FDA announced on Dec. 22, 2023, that Onkos Surgical, Inc. is recalling the ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM due to mislabeling hazards. The agency classified this Class II recall as voluntary and ongoing.
How to tell if you have it
Brand: Onkos Surgical
Product: ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM
Model Number: HC-15120-03M
UDI-DI: B278HC1512003M0
Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123)
Quantity: 23 units
The hazard
The recall addresses the mislabeling of 13mm Modular Segmental Stem packages (HC-13120-03M) which included an implant that was 15mm in diameter instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Context
GovInfoNow's records show Onkos Surgical, Inc. has had four other recalls since Sept. 1, 2023, including a July 11, 2025 recall for unidentified substances and a May 20, 2025 recall for missing inspections. Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026), and the DeRoyal Myocardial Probe Recall (Aug. 20, 2026).
How to tell if you have this one
Check for model number HC-15120-03M on the product. Serial numbers start with P230274-1 and go up to P230274-123. The product is part of a limb salvage system with BioGrip.
Brand
Onkos Surgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Recall number
Product, codes & lots
Z-1817-2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.; Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Z-1818-2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.; Model Number: HC-15120-03M. UDI-DI: B278HC1512003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the model number and serial numbers to confirm if your ELEOS Collar Stem is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California, Kentucky, and Wisconsin.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Kentucky, Wisconsin.
Recall timeline
FDA published this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall addresses a potential risk of improper implant fitting during surgery, but no specific injuries have been reported. The hazard is low risk as it relates to surgical procedures.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1818-2025 (December 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1818-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.