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Medium risk Medical DevicesClass II

U2 Total Knee System Adaptor Recall

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software

Updated May 20, 2026

United Orthopedic's U2 Total Knee System femoral valgus adaptor components have a defective screw that prevents proper assembly of the stem trail. This could compromise the stability and function of the knee implant.

Is the United Orthopedic Corp. recalled? Yes. This product was recalled by FDA on May 20, 2026. Details below.

What is recalled

U2 Total Knee System Femoral valgus adaptor (left and right), model numbers 9323-5333 and 9323-5334, manufactured by United Orthopedic Corp.

Am I affected

You are affected if you have had a U2 Total Knee System implant using femoral valgus adaptor model 9323-5333 (left) or 9323-5334 (right), or if you are a healthcare facility that has these components in inventory.

What to do right now

Contact United Orthopedic Corp. immediately if you or your facility has received or implanted these components. Do not use model 9323-5333 or 9323-5334 for new implants. If you have had this implant, consult your surgeon about whether any follow-up evaluation or action is needed.

The hazard

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Brands affected

United Orthopedic Corp.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2885-2026
Classification
Class II
Recalled
May 20, 2026
Read the official notice

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