Brand Name: USTAR II Knee System Product Name: Hinge Box Trial — Class II medical device recall Z-2884-2026
Ongoing recall by United Orthopedic Corp., reported 2026-08-12, distributed nationwide. Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling
| Recall number | Z-2884-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corp., Kaohsiung, Taiwan |
| Recall initiated | 2026-05-20 |
| Classified | 2026-08-05 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| UPC / GTIN / UDI-DI | 04719886907032, 04719886907049, 04719886907056, 04719886907063, 04719886907070, 04719886907087, 04719886907094, 04719886907100, 04719886907117, 04719886907124, 04719886907131, 04719886907148 |
| Lot numbers | 25FB35, 25FB36, 25FB37, 25FB38, 25FB39, 25FB40, 25FB41, 25FB42, 25FB43, 25FB44, 25FB45, 25FB46 |
| Model numbers | 9325-5711 |
Product
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Reason for recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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-2884-2026. 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.