United Orthopedics USTAR II Knee System USTAR II Knee System Segment… — Class II medical device recall Z-0110-2022
Terminated recall by Uoc Usa Inc, reported 2021-10-20, distributed nationwide. Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue
| Recall number | Z-0110-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Uoc Usa Inc, Irvine, CA, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-10-13 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2023-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 3 devices |
| UPC / GTIN / UDI-DI | 04719872148197 |
| Lot numbers | 19E272H |
| Model numbers | 2915-1025 |
Product
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Reason for recall
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
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-0110-2022. 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.