FDA Medical devices recall ·
U2 Total Knee System Product Name: Femoral valgus adaptor… recall
- Recall number
- Z-2885-2026
- Date
- (initiated May 20, 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
- 2
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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
Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
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-2885-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.