Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333…
United Orthopedic Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: United Orthopedic Corp. · No. 16 Luke 1st Rd., Luzhu Dist. · Kaohsiung
Is this the product you have?
- Brand NameU2
- Total Knee System Product NameFemoral valgus adaptor
- left and right Model/Catalog Number9323-5333
- and 9323-5334 Software VersionN/A
- Product DescriptionManual Orthopedic
- Surgical Instrument ComponentNo
- Lot codes and dates
- Product Number; UDI-DI Code
- Lot Code
Product number 9323-5333UDI-DI 04719886908084Lot number 25FB50 Product number 9323-5334UDI-DI 04719886908091Lot number 25FB51
- Amount recalled
- 2
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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