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 | 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. |
| Product | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip. |
| Quantity | 23 units |
| Distribution | US Nationwide distribution in the states of California, Kentucky, and Wisconsin. |
| Initiated | 2023-12-22 |
| Classified | 2025-05-23 |
| Recall number | Z-1818-2025 |
| 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-1818-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96781/
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