Segmental Stem — Class II medical device recall Z-1881-2025
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-1881-2025 |
|---|---|
| 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 | 120 units |
| Lot numbers | 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543, 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553, 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563, 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571 and 80 more |
| Model numbers | FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M |
Product
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS 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-1881-2025. 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.