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Medium risk Medical DevicesClass II

United Orthopedic Corp. 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 Corp. is recalling Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software. Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

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

What is recalled

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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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