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Lower risk Medical device recall · FDA · Published May 19, 2026

Howmedica Triathlon Baseplate Size 3 Recall: Confusing Labeling Risk

Howmedica recalls Triathlon Universal Baseplate Size 3 (part 5521-B-300) due to labeling errors causing confusion with Size 4 models. Affected units may have incorrect lot numbers.

🇺🇸 FDA recall #Z-2461-2026Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Howmedica is recalling Triathlon Universal Baseplate Size 3 (part number 5521-B-300) because it's mistakenly labeled as Size 4 in some packaging. This confusion could lead to using the wrong size plate, which might cause improper installation or injury during surgery. Read more at govinfonow.com/recall/49148-howmedica-triathlon-baseplate-size-3-recall-confusing-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49148-howmedica-triathlon-baseplate-size-3-recall-confusing-labeling-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2461-2026

Cite this page

“Howmedica Triathlon Baseplate Size 3 Recall: Confusing Labeling Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49148-howmedica-triathlon-baseplate-size-3-recall-confusing-labeling-risk. Based on FDA recall #Z-2461-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2461-2026%22&limit=1).

Why it’s dangerous

The baseplate is labeled incorrectly in packaging, causing confusion between Size 3 and Size 4 models. Using the wrong size could lead to improper installation during surgery, potentially causing injury to patients.

Who’s affected

Orthopedic surgeons and medical staff who use these baseplates for surgical procedures. Those who have the specific lot number UZD9IB are most at risk.

How to tell if you have this one

Check for part number 5521-B-300 and lot number UZD9IB on the packaging. The product may be labeled as Triathlon Universal Baseplate Size 4 but contains the Size 3 model.

  • Brand
    Howmedica
  • Product
    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300
  • 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
    Ongoing
  • Distribution
    US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
Recall numberProduct, codes & lots
Z-2461-2026TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.; Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.
Z-2462-2026TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.; Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Labels

    Look for part number 5521-B-300 and lot number UZD9IB on the packaging to confirm if the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Georgia, Michigan, New Jersey, New York, North Carolina, West Virginia.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: May 19, 202612. FDA classified it Class II: Jun 17, 202623. Published in FDA’s Enforcement Report: Jun 24, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2461-2026 (May 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2461-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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