Brand Name: U2 Total Knee System Product Name: PSA Box Trial — Class II medical device recall Z-2883-2026
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-2883-2026 |
|---|---|
| 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 | 04719886906424, 04719886906929, 04719886906936, 04719886906943, 04719886906950, 04719886906967, 04719886906974, 04719886906981, 04719886906998, 04719886907001, 04719886907018, 04719886907025 |
| Lot numbers | 25FB29, 25FB30, 25FB31, 25FB32, 25FB33, 25FB34, 25FB54, 25FB55, 25FB56, 25FB57, 25FB58, 25FB59 |
| Model numbers | 9323-5511 |
Product
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 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-2883-2026. 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.