FDA Medical devices recall ·
U2 Total Knee System Product Name: Femoral offset bushing… recall
- Recall number
- Z-2897-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- United Orthopedic Corp.
No. 16 Luke 1st Rd., Kaohsiung, Taiwan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
Distribution
US Nationwide distribution in the states of Texas and Michigan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2897-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.