Reported Aug 12, 2026 · Ongoing
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog…
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 NameUSTAR
- II Knee System Product NameHinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6
- Model/Catalog Number9325-5711 thru 9325-5716 and 9325-5721
- thru 9325-5726 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 9325-5711Lot Code — 04719886907032UDI-DI 04719886907032 9325-5712Lot number 25FB41 — 04719886907049UDI-DI 04719886907049 9325-5713Lot number 25FB42 — 04719886907056UDI-DI 04719886907056 9325-5714Lot number 25FB43 — 04719886907063UDI-DI 04719886907063 9325-5715Lot number 25FB44 — 04719886907070UDI-DI 04719886907070 9325-5716Lot number 25FB45 — 04719886907087UDI-DI 04719886907087 9325-5721Lot number 25FB46 — 04719886907094UDI-DI 04719886907094 9325-5722Lot number 25FB35 — 04719886907100UDI-DI 04719886907100 9325-5723Lot number 25FB36 — 04719886907117UDI-DI 04719886907117 - 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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