United Orthopedic Corp. recalls U2 Total Knee System femoral offset bushings (model 9323-5310) due to potential incorrect implant orientation from engraved numbering errors.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings (0mm and 4mm models) because the engraved numbering may be incorrect, leading to improper implant alignment during surgery. This could cause improper joint function or complications after surgery.
The engraved numbering on the bushing may be incorrect, which could lead to the implant being oriented improperly during surgery. This might cause improper joint alignment and potential complications after the procedure.
Surgical teams using the U2 Total Knee System femoral offset bushings (model 9323-5310) are affected. Surgeons and medical staff performing knee replacements are most at risk if the bushing is used incorrectly.
Check for the model number 9323-5310 on the U2 Total Knee System femoral offset bushing (0mm or 4mm). The product was sold with lot code 25FC58 and UDI-DI 04719886908060.
Verify the model number 9323-5310 on the femoral offset bushing (0mm or 4mm) to confirm if it's affected.
The recall applies to surgical instruments used in knee replacements. If you have the specific model 9323-5310, contact your surgeon to discuss potential risks.
Look for the model number 9323-5310 on the U2 Total Knee System femoral offset bushing (0mm or 4mm). The product was sold with lot code 25FC58 and UDI-DI 04719886908060.
The recall does not require immediate action. Check the product details to confirm if it's affected; if so, contact your surgeon for guidance.
We’ve drafted a message you can send U2 to request your refund or repair — edit it as you like.
Subject: Recall Z-2897-2026 — U2 U2 Hello, I own a U2 that is covered by recall Z-2897-2026 from U2. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
