U2 Total Knee System Femoral Valgus Adaptor Recall: Assembly Risk

✎ GovInfoNow plain-language explainer

What happened, in plain English

United Orthopedic Corp. is recalling U2 Total Knee System Femoral Valgus Adaptors (models 9323-5333 and 9323-5334) because a manufacturing defect may prevent proper assembly. This could lead to improper surgical outcomes if used in knee replacements.

Why it’s dangerous

The adaptor may not assemble correctly due to a manufacturing defect in the component screw. This could lead to improper alignment during knee replacement surgery, potentially causing surgical complications.

Who’s affected

Patients who received the U2 Total Knee System Femoral Valgus Adaptors (models 9323-5333 and 9323-5334) during surgery are affected. Surgeons and surgical teams using these components are at risk of improper assembly.

How to tell if you have this one

Check for model numbers 9323-5333 or 9323-5334 on the surgical instrument packaging. The lot numbers are 25FB50 or 25FB51 for these models.

Brand
U2
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to United Orthopedic Corp. for specific guidance on handling the recalled instruments.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to an incomplete process of the component screw by a subcontractor, which may prevent proper assembly of the stem trail during knee replacement surgery.

What models are affected?

Models 9323-5333 and 9323-5334 with lot numbers 25FB50 and 25FB51 respectively.

Do I need to stop using this product?

The recall does not specify a stop-use instruction; contact United Orthopedic Corp. for guidance.

Take action

Contact U2

We’ve drafted a message you can send U2 to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2885-2026 — U2 U2

Hello,

I own a U2 that is covered by recall Z-2885-2026 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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Where this comes from

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.

Official source: FDA Recall #Z-2885-2026 (May 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2885-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333

Lower-risk recall