Ethos Collar Stem — Class II medical device recall Z-1883-2025

Ongoing recall by Onkos Surgical, Inc., reported 2025-06-04, distributed in AZ, FL, GA, HI, IL, KS, KY, LA…. Potential for breach of Tyvek seals.

Recall number	`Z-1883-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Onkos Surgical, Inc., Parsippany, NJ, United States
Recall initiated	2023-09-01
Classified	2025-05-29
Reported by FDA	2025-06-04
Distributed	AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NC, NE, NJ, OH, PA, TX, WA, WI
Quantity	233 units
Lot numbers	`1880652`, `1880653`, `1880654`, `1880655`, `1880656`, `1880657`, `1880658`, `1880659`, `1880660`, `1880661`, `1880662`, `1880663`, `1880664`, `1880665`, `1880666`, `1880667`, `1880668`, `1880669`, `1880670`, `1880671`, `1880672`, `1880673`, `1880674`, `1880675`, `1880676`, `1880677`, `1880678`, `1880679`, `1880680`, `1880681`, `1880682`, `1880683`, `1880684`, `1880685`, `1880686`, `1880687`, `1880688`, `1880689`, `1880690`, `1880691` and 193 more
Model numbers	`HC-09100-03M`, `HC-10100-03M`, `HC-11120-03M`, `HC-13120-03M`, `HC-15120-03M`, `HC-17120-03M`

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

Reason for recall

Potential for breach of Tyvek seals.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1883-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.