ELEOS COLLAR STEM — Class II medical device recall Z-1818-2025
Ongoing recall by Onkos Surgical, Inc., reported 2025-06-04, distributed nationwide. Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in d
| Recall number | Z-1818-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Onkos Surgical, Inc., Parsippany, NJ, United States |
| Recall initiated | 2023-12-22 |
| Classified | 2025-05-23 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 23 units |
| Reason classes | labeling |
| Serial numbers | P230274-1XX |
| Model numbers | HC-15120-03M |
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Reason for recall
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.
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-1818-2025. 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.