Brand Name: U2 Total Knee System Product Name: Femoral recall
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product…
Why was Brand Name: U2 Total Knee System Product Name: Femoral 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 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?
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
- 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…
- Recalling firm
- United Orthopedic Corp.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)