United Orthopedic Corp. recalls U2 Total Knee System femoral offset bushings (model 9323-5312) due to incorrect engraving causing potential implant misalignment during surgery.
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 (2mm and 6mm models) because the engraving on these surgical components may be incorrect. This could lead to improper implant positioning during knee surgery, potentially affecting surgical outcomes.
The bushings have incorrect engraved numbering that could cause the implant to be oriented improperly during surgery. This might lead to surgical complications if the implant is not positioned correctly in the patient's knee joint.
Surgical teams using the U2 Total Knee System femoral offset bushings (model 9323-5312) for knee replacements are affected. Surgeons and hospitals that have purchased these components are most at risk.
Check for the model number 9323-5312 on the U2 Total Knee System femoral offset bushings (2mm and 6mm sizes). These were sold with lot code 25FC64 and UDI-DI 04719886908077.
Verify the model number on the bushing (9323-5312) and lot code (25FC64) to confirm if it's affected.
The recall applies to surgical components used in knee replacements, but it does not affect completed surgeries. Only the specific bushings with model 9323-5312 are affected.
Look for the model number 9323-5312 and lot code 25FC64 on the bushing. These were sold with UDI-DI 04719886908077.
The recall does not require immediate action. The manufacturer has not provided a remedy, so users should check the product details to confirm if it's affected.
We’ve drafted a message you can send U2 to request your refund or repair — edit it as you like.
Subject: Recall Z-2898-2026 — U2 U2 Hello, I own a U2 that is covered by recall Z-2898-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
