Brand Name: U2 Total Knee System Product Name: Femoral valgus offset… — Class II medical device recall Z-2886-2026
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-2886-2026 |
|---|---|
| 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 | 04719886906554, 04719886906561, 04719886906578, 04719886906585, 04719886906592, 04719886906608 |
| Lot numbers | 25FB48, 25FB49, 25FB52, 25FB53, 25FB64, 25FB65 |
| Model numbers | 9323-5335, 9323-5336, 9323-5337, 9323-5338, 9323-5339, 9323-5340 |
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
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-2886-2026. 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.