Brand Name: U2 Total Knee System Product Name: Femoral offset bushing — Class II medical device recall Z-2897-2026
Ongoing recall by United Orthopedic Corp., reported 2026-08-12, distributed nationwide. Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect o
| Recall number | Z-2897-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corp., Kaohsiung, Taiwan |
| Recall initiated | 2026-03-19 |
| Classified | 2026-08-06 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| UPC / GTIN / UDI-DI | 04719886908060 |
| Lot numbers | 25FC58 |
| Model numbers | 9323-5310 |
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Reason for recall
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
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-2897-2026. 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.