UnratedMedical device recall · FDA · Published July 11, 2025
Onkos Surgical ELEOS Limb Salvage System Recall: Unidentified Substance Found
Onkos Surgical recalls ELEOS Segmental Limb Salvage System implants with unidentified substance. Affected models were sold before July 11, 2025. No remedy specified in recall notice.
“Onkos Surgical ELEOS Limb Salvage System Recall: Unidentified Substance Found.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51811-onkos-surgical-eleos-limb-salvage-system-recall-unidentified-substance-found. Based on FDA recall #Z-2425-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2025%22&limit=1).
Onkos Surgical, Inc. recalled ELEOS SEGMENTAL LIMB SALVAGE SYSTEM and ELEOS STEM EXTENSION implants due to an unidentified substance found on the devices, the FDA announced July 11, 2025.
An unidentified substance of unknown impact was identified on the devices during a retrospective evaluation, according to the FDA.
Context
GovInfoNow's records show Onkos Surgical, Inc. has issued four other recalls since September 1, 2023. Other recent recalls include the My3D Humeral Cup Recall on May 20, 2025, and the ELEOS Midsection Recall on September 22, 2024.
How to tell if you have this one
Check for model numbers KSP17100E through KSP22100E on the implant packaging. Products were sold before July 11, 2025, and have unique identifiers starting with B278KSP.
Brand
Onkos Surgical
Category
Medical device
FDA recall event · 3 products
All 3 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 AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
Recall number
Product, codes & lots
Quantity
Z-2423-2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.; Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.
30 units
Z-2424-2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.; Model No. 2500CP16E; UDI: B2782500CP16E0; Lot No. All lots released prior to 2025-07-11.
15 units
Z-2425-2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.; Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11.
554 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the model number and unique identifier on the implant packaging to confirm if it matches the recalled models.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 25 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Tennessee, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA published this recall 54 days 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 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-2425-2025 (July 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2425-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.