United Orthopedic Corp. U2 Total Knee System Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 |
|---|---|
| Lot / date codes | 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 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.