The Recall Desk

FDA (Devices) recall action 99025

United Orthopedic Corp. recalled 2 products on 2026-08-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-08-12
Critical
0
Units
6

Why these products were recalled

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2026-08-12

    United Orthopedic U2 Knee Implant Bushings Recalled Over Engraving Design Issue

    United Orthopedic Corp. is recalling three Femoral offset bushing components of the U2 Total Knee System due to a design issue causing incorrect engraved numbering that could lead to incorrect implant orientation during surgery.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2026-08-12

    United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings

    United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Distribution
    2 states