USTAR II Hip System Press-Fit Curved Stem — Class II medical device recall Z-1215-2024
Ongoing recall by United Orthopedic Corporation, reported 2024-03-06, distributed in CA, CO, FL, IN, KY, MI, NV, TN…. Their is a potential that the implant curved stem may be oriented incorrectly.
| Recall number | Z-1215-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corporation, Hsinchu, Taiwan |
| Recall initiated | 2024-01-03 |
| Classified | 2024-02-29 |
| Reported by FDA | 2024-03-06 |
| Distributed | CA, CO, FL, IN, KY, MI, NV, TN, TX |
| Countries outside the US | CH, GB, MY, PH, TW |
| Quantity | 598 units |
| UPC / GTIN / UDI-DI | 04719872149866, 04719872153863, 04719872153870, 04719872153887, 04719872153894, 04719872153900, 04719872153917, 04719872153924 |
| Lot numbers | 15E198AA, 15E198AA12, 15E198AA22, 15E198AA23, 15E198S11, 15E198S12, 15E198W11, 15E198W111, 15E198X, 15E198X21, 15E198Y, 15E198Y11, 15E198Z, 15E198Z111, 15E198Z22, 15E198Z3, 16C168H, 16C168H21, 16C168H3, 16C168J, 16C168R1, 17H618E, 17H618E1, 17H618E2, 18A004A, 18A004B, 18A004B111, 18A004C2, 18A004C31, 18A004D, 18A004D1, 18A004D21, 18A004D22, 18A004E, 18A004E1, 18A004E112, 18A004F, 18A004F111, 18A004F211, 18A004F212 and 78 more |
| Model numbers | 11X150MM, 11X200MM, 13X150MM, 13X200MM, 15X150MM, 15X200MM, 17X150MM, 17X200MM, PE11151211, PE11151213, PE11151215, PE11151217, PE11151411, PE11151413, PE11151415, PE11151417 |
Product
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
Reason for recall
Their is a potential that the implant curved stem may be oriented incorrectly.
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-1215-2024. 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.