Reported Aug 12, 2026 · Ongoing
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus…
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 Name
Femoral valgus offset adaptor2mm4mm6mmleft and Femoral valgus offset adaptor2mm4mm6mm
- right Model/Catalog Number
9323-53359323-53379323-5339 and 9323-53369323-53389323-5340
- Software VersionN/A
- Product DescriptionManual Orthopedic
- Surgical Instrument ComponentNo
- Lot codes and dates
15 of 15 products
Products covered by this recall Model / number Barcodes Product as published — Product Number — UDI-DI Code 9323-5335Lot Code — 04719886906554UDI-DI 04719886906554 9323-5337Lot number 25FB64 — 04719886906578UDI-DI 04719886906578 9323-5339Lot number 25FB48 — 04719886906592UDI-DI 04719886906592 9323-5336Lot number 25FB52 — 04719886906561UDI-DI 04719886906561 9323-5338Lot number 25FB65 — 04719886906585UDI-DI 04719886906585 9323-5340Lot number 25FB49 — 04719886906608UDI-DI 04719886906608 — Lot number 25FB53 - 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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