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Lower risk Medical device recall · FDA · Published September 29, 2017

Zimmer Biomet Knee Implant Recall: Incorrect Size Labeling

Zimmer Biomet recalls Vanguard Complete Knee System with incorrect tibial bearing size labels. This may cause improper fit during surgery. Affected units sold between 2021-2022.

🇺🇸 FDA recall #Z-0674-2018Medical deviceZimmer Biomet ›
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Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer Biomet is recalling knee implants with incorrectly labeled tibial bearings. This could lead to improper surgical fit if the wrong size is used during knee replacement procedures. Read more at govinfonow.com/recall/72927-zimmer-biomet-knee-implant-recall-incorrect-size-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/72927-zimmer-biomet-knee-implant-recall-incorrect-size-labeling · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0674-2018

Cite this page

“Zimmer Biomet Knee Implant Recall: Incorrect Size Labeling.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72927-zimmer-biomet-knee-implant-recall-incorrect-size-labeling. Based on FDA recall #Z-0674-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0674-2018%22&limit=1).

Why it’s dangerous

The tibial bearings are labeled with the wrong size, which could lead to improper surgical fit. This might cause complications during knee replacement procedures if the incorrect size is used.

Who’s affected

Patients who received this specific knee implant during surgery between 2021 and 2022 are affected. Surgeons and medical facilities using these implants are most at risk.

How to tell if you have this one

Check for the item number 183540 on the implant packaging. The product was sold for use in total knee arthroplasty with lot number 473290 and expired May 19, 2022.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
Recall numberProduct, codes & lots
Z-0673-2018Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty; Lot Number: 388680, Exp. Date 5/19/2022
Z-0674-2018Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty; Lot Number: 473290, Exp. Date 5/19/2022
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Packaging

    Look for item number 183540 on the implant packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Ohio, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Sep 29, 201712. FDA classified it Class II: Feb 21, 201823. Published in FDA’s Enforcement Report: Feb 28, 201834. FDA terminated the recall: Apr 17, 2019420172019
  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.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for incorrect size labeling, which could lead to improper surgical fit. However, the hazard level is low risk as it does not cause immediate injury in normal use.

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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-0674-2018 (September 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0674-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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