Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
| Recalling firm | United Orthopedic Corp. |
|---|---|
| Reason | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 12, 2026 |
| Initiated | May 20, 2026 |
| Region | Taiwan |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| Quantity | 2 |
| Code/Lot | Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51 |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2885-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2885-2026)
openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)
Find out more
- Search this recall on FDA fda.gov ↗
- Search related news (Google News) news.google.com ↗
- Search this product (Google) google.com ↗
The links above open external searches by recall number / product name; the results are the responsibility of each site.
This page summarizes U.S. FDA data for general information and is not medical advice. Confirm details via official FDA announcements and the manufacturer.