Class II — Onkos Surgical, Inc.
| Recalling firm | Onkos Surgical |
|---|---|
| Registered facility | ONKOS SURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Product | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. |
| Quantity | 15 units |
| 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. |
| Initiated | 2025-07-11 |
| Classified | 2025-08-25 |
| Recall number | Z-2424-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Onkos Surgical, Inc. (Z-2424-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97343/
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