United Orthopedic Corp. recalls U2 Total Knee System femoral valgus offset adaptors (2mm, 4mm, 6mm) due to incomplete component screwing, which may prevent proper stem assembly during surgery.
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 U2 Total Knee System femoral valgus offset adaptors (2mm, 4mm, 6mm models) because a manufacturing defect may prevent proper assembly of the knee implant during surgery. This could lead to improper surgical outcomes if the device is used without correction.
The adaptors may not assemble correctly due to an incomplete screwing process by a subcontractor. This could result in improper alignment of the knee implant during surgery, potentially affecting the surgical outcome.
Orthopedic surgeons and medical professionals who use the U2 Total Knee System femoral valgus offset adaptors for knee replacements. Patients are not directly affected as the device is used by medical staff during surgery.
Check for model numbers 9323-5335, 9323-5337, 9323-5339, 9323-5336, 9323-5338, or 9323-5340 on the product. These are used in left and right knee replacements.
Verify the model number on the product to confirm it is one of the recalled items (9323-5335, 9323-5337, 9323-5339, 9323-5336, 9323-5338, 9323-5340).
The recall is due to an incomplete screwing process by a subcontractor, which may prevent proper assembly of the knee implant during surgery.
The recall does not specify a remedy, so no action is required beyond checking if you have the recalled model numbers.
The product may not assemble correctly, which could affect surgical outcomes, but the recall does not indicate a risk to patients during normal use.
We’ve drafted a message you can send U2 to request your refund or repair — edit it as you like.
Subject: Recall Z-2886-2026 — U2 U2 Hello, I own a U2 that is covered by recall Z-2886-2026 from U2. 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.
