Class II — Onkos Surgical, Inc.
| Recalling firm | Onkos Surgical |
|---|---|
| Registered facility | ONKOS SURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
| Product | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E |
| Quantity | 4 units |
| Distribution | AZ, IL & KS |
| Initiated | 2017-05-23 |
| Classified | 2017-06-29 |
| Terminated | 2018-06-27 |
| Recall number | Z-2646-2017 |
| 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-2646-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77309/
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