Brand Name: U2 Total Knee System Product Name: Femoral recall
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version…
Why was Brand Name: U2 Total Knee System Product Name: Femoral recalled?
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- United Orthopedic Corp.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)