United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial implants (models 9323-5511 to 9323-5526) due to incomplete screw assembly that may prevent proper fitting. Affected patients should contact the manufacturer for details.
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 PSA Box Trial implants (left and right) with model numbers 9323-5511 through 9323-5526. The recall is because a manufacturing defect may prevent the implants from assembling correctly, which could lead to improper joint function.
The implants may not assemble correctly because the component screw was not fully processed during manufacturing. This defect could prevent the stem from fitting properly, potentially causing joint instability or improper movement.
Patients who received the PSA Box Trial implants (left or right) with model numbers 9323-5511 to 9323-5526 from United Orthopedic Corp. are most at risk if the implants do not assemble properly.
Check for model numbers 9323-5511 through 9323-5526 on the U2 Total Knee System PSA Box Trial implants (left or right). The product is a reusable knee femur prosthesis trial implant.
Reach out to United Orthopedic Corp. for specific guidance on the recalled implants and next steps.
The recalled implants have model numbers 9323-5511 through 9323-5526 (left and right).
The recall is due to an incomplete manufacturing process that may prevent the component screw from assembling properly with the stem.
The recall does not require immediate discontinuation; contact United Orthopedic Corp. for specific guidance.
We’ve drafted a message you can send U2 to request your refund or repair — edit it as you like.
Subject: Recall Z-2883-2026 — U2 U2 Hello, I own a U2 that is covered by recall Z-2883-2026 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.
