FDAClass II · Medical device · Recall Z-2897-2026 · Recalled August 12, 2026

Brand Name recall — United Orthopedic Corp.

Agency report date: August 12, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Brand Name
Company / brand: United Orthopedic
Lot / serial / date codes: Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
Distribution: US Nationwide distribution in the states of Texas and Michigan.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2897-2026
Brand: United Orthopedic
Classification: Class II
Units affected: 3
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Brand Name

Companies & origin

Recalling firm location: Kaohsiung, Taiwan
Firm address: No. 16 Luke 1st Rd., Luzhu Dist., N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
Distribution: US Nationwide distribution in the states of Texas and Michigan.
Firm notified the public via: Letter
FDA event ID: 99025
Recall initiated: March 19, 2026
FDA classified: August 6, 2026
FDA report date: August 12, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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