Aesculap Univation X Knee Implants: Potential Revision Surgery Risk

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Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Aesculap is recalling certain Univation X System knee implants that may loosen over time, potentially requiring revision surgery. This recall affects patients who received these specific implant models.

Why it’s dangerous

The implants may loosen over time, which could lead to the need for additional surgery to correct the issue. This malfunction is not immediate but occurs during normal use after implantation.

Who’s affected

Patients who received the Univation X System knee implants with model numbers NL470 through NL475 are most at risk. These implants were sold with all production lots.

How to tell if you have this one

Check if your knee implant has model numbers NL470 through NL475. These specific models were sold with all production lots.

Brand
Aesculap
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Implant Model
Identify your implant model number to see if it matches NL470 through NL475.

✎ GovInfoNow

Questions people ask

Do I need to get surgery immediately?

The recall states a potential need for revision surgery if the implant loosens, but this is not immediate. Contact your surgeon for advice.

How can I tell if my implant is affected?

Check the model number on your implant; affected models are NL470 through NL475 with all production lots.

Is there a fix for this issue?

The recall does not mention a fix or remedy; affected patients should contact their surgeon about potential revision surgery.

Take action

Contact Aesculap

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

✉️ Open in email

Subject: Recall Z-2509-2021 — Aesculap Aesculap

Hello,

I own a Aesculap that is covered by recall Z-2509-2021 from Aesculap.

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-2509-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2509-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;

Lower-risk recall