United Orthopedic Corp. U2 Total Knee System Recall (Unknown Date)
Announced 2026-08-12 · FDA
The recall affects United Orthopedic Corp.'s U2 Total Knee System femoral offset bushing components (0 mm and 4 mm) with model 9323-5310, distributed in the US including Texas and Michigan. A design issue could cause incorrect engraved numbering on the implant, potentially resulting in incorrect orientation of the implant. Lot code 25FC58 and UDI-DI 04719886908060 are provided to identify affected items.
| Brand | United Orthopedic Corp. |
|---|---|
| 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 |
| Reason | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| Severity | moderate |
| Units affected | 2 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 |
WHAT YOU SHOULD DO
- Contact your surgeon or hospital to discuss this recall if you have had a knee replacement involving the affected implant.
- Provide your device information (lot 25FC58 and UDI 04719886908060) to your clinician if requested and arrange any recommended imaging or follow-up.
- Do not attempt to modify or replace implants or components yourself; follow your clinician's guidance for evaluation and action.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.