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 | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. |
| Product | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System |
| Quantity | 24 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN. |
| Initiated | 2024-09-22 |
| Classified | 2025-05-28 |
| Recall number | Z-1857-2025 |
| 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-1857-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96780/
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