ELEOS SEGMENTAL LIMB SALVAGE SYSTEM — Class II medical device recall Z-2425-2025
Ongoing recall by Onkos Surgical, Inc., reported 2025-09-03, distributed nationwide. Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
| Recall number | Z-2425-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Onkos Surgical, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-07-11 |
| Classified | 2025-08-25 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 554 units |
| Model numbers | KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E |
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Reason for recall
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2425-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.