Reported Aug 12, 2026 · Ongoing
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310…
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. · Kaohsiung · N/A
Is this the product you have?
- Brand NameU2
- Total Knee System Product NameFemoral offset bushing, 0mm
- and 4mm Model/Catalog Number9323-5310
- Software VersionN/A
- Product DescriptionManual Orthopedic
- Surgical Instrument ComponentNo, N/A
- Lot codes and dates
- Lot Code
Product Number 9323-5310UDI-DI 04719886908060Lot number 25FC58
- Lot Code
- Amount recalled
- 3
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 a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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