OVERLOOKED

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Class IIOngoing

United Orthopedic Corp. recalls 2 products

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
United Orthopedic Corp.
Reason
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of Texas and Michigan.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99025…

Products (2)

  1. 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

    Codes/lots: Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58Quantity: 3Recall no. Z-2897-2026Class II

  2. 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

    Codes/lots: Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64Quantity: 3Recall no. Z-2898-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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