Reported Aug 12, 2026 · Ongoing
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:…
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 NamePSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6
- Model/Catalog Number9323-5511 thru 9323-5516 and 9323-5521
- thru 9323-5526 Software VersionN/A
- Product DescriptionKnee femur prosthesis trial
- reusable ComponentNo, N/A
- Lot codes and dates
27 of 27 products
Products covered by this recall Model / number Barcodes Product as published — Product Number — UDI-DI Code 9323-5511Lot Code — 04719886906929UDI-DI 04719886906929 9323-5512Lot number 25FB54 — 04719886906936UDI-DI 04719886906936 9323-5513Lot number 25FB55 — 04719886906943UDI-DI 04719886906943 9323-5514Lot number 25FB56 — 04719886906950UDI-DI 04719886906950 9323-5515Lot number 25FB57 — 04719886906967UDI-DI 04719886906967 9323-5516Lot number 25FB58 — 04719886906424UDI-DI 04719886906424 9323-5521Lot number 25FB59 — 04719886906974UDI-DI 04719886906974 9323-5522Lot number 25FB29 — 04719886906981UDI-DI 04719886906981 9323-5523Lot number 25FB30 — 04719886906998UDI-DI 04719886906998 - 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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