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Lower risk Medical device recall · FDA · Published August 10, 2017

Aesculap Vega Knee Plateau Size T4 Recall: Risk of Wrong Implant Size

Aesculap recalls Vega Knee System component NS357R size T4 due to possible incorrect labeling. Using the wrong size may cause ligament injury, pain, or revision surgery.

🇺🇸 FDA recall #Z-0591-2018Medical deviceAesculap ›
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Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aesculap is recalling a specific knee surgery component that may be incorrectly labeled. Using the wrong size could lead to ligament injury, pain, or needing additional surgery. Read more at govinfonow.com/recall/73151-aesculap-vega-knee-plateau-size-t4-recall-risk-of-wrong.

Source Summary by GovInfoNow · govinfonow.com/recall/73151-aesculap-vega-knee-plateau-size-t4-recall-risk-of-wrong · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0591-2018

Cite this page

“Aesculap Vega Knee Plateau Size T4 Recall: Risk of Wrong Implant Size.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73151-aesculap-vega-knee-plateau-size-t4-recall-risk-of-wrong. Based on FDA recall #Z-0591-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0591-2018%22&limit=1).

Why it’s dangerous

The component may have the wrong size label. If used incorrectly, it could cause ligament damage, pain, or require revision surgery.

Who’s affected

Patients undergoing knee reconstruction surgery who use the Vega Knee System Set #ST0468 are affected. Those with the NS357R size T4 plateau component are at risk.

How to tell if you have this one

Check if your Vega Knee System Set #ST0468 includes the NS357R Vega PS Tibia Trial/Preparation Plateau size T4. This part is in the Vega Tibia preparation Tray (NS803) within the Vega Instrument Set (ST0468).

  • Brand
    Aesculap
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Component Label

    Verify the size label on the NS357R Vega PS Tibia Trial/Preparation Plateau to ensure it matches the correct size.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA (nationwide)” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Aug 10, 201712. FDA classified it Class II: Feb 12, 201823. Published in FDA’s Enforcement Report: Feb 21, 201834. FDA terminated the recall: Aug 8, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-0591-2018 (August 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0591-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA