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 for breach of Tyvek seals. |
| Product | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM |
| Quantity | 233 units |
| Distribution | Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI. |
| Initiated | 2023-09-01 |
| Classified | 2025-05-29 |
| Recall number | Z-1883-2025 |
| 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-1883-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96782/
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