United Orthopedic Corp. recalls USTAR II Knee System Hinge Box Trial models due to incomplete screw assembly preventing proper stem trail. Affected units include specific model numbers and lot codes.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trial models (left and right) because a subcontractor's incomplete screw process may prevent proper assembly. This could lead to improper knee joint function during surgery.
The component screw was not fully processed by a subcontractor, which means the hinge box may not assemble correctly with the stem. This could cause improper alignment of the knee joint during surgery, potentially leading to complications.
Patients who received the recalled USTAR II Knee System Hinge Box Trial models (left and right) during surgery are most at risk. The recall affects specific model numbers and lot codes used in knee replacement procedures.
Check if your USTAR II Knee System Hinge Box Trial has model numbers 9325-5711 to 9325-5716 or 9325-5721 to 9325-5726. Lot numbers 25FB41 to 25FB46 are also affected.
Verify your USTAR II Knee System Hinge Box Trial model and lot number against the listed numbers to confirm if it's affected.
The recall is due to an incomplete screw process by a subcontractor that prevents proper assembly of the stem trail, which could lead to improper knee joint alignment during surgery.
Check if your product has model numbers 9325-5711 to 9325-5716 or 9325-5721 to 9325-5726 with lot numbers 25FB41 to 25FB46.
The recall does not require immediate action; you should check your product details to confirm if it's affected.
We’ve drafted a message you can send USTAR II to request your refund or repair — edit it as you like.
Subject: Recall Z-2884-2026 — USTAR II USTAR II Hello, I own a USTAR II that is covered by recall Z-2884-2026 from USTAR II. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
