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Lower risk Medical device recall · FDA · Published September 26, 2025

Zimmer Biomet Dual Mobility Vivacit-E Bearing Recall: Size Mixup Risk

Zimmer Biomet recalls two lots of Dual Mobility Vivacit-E bearings due to size mixup between Size F and Size G implants. This mismatch could cause improper joint fit and complications during surgery.

🇺🇸 FDA recall #Z-0418-2026Medical deviceZimmer ›
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Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling two lots of Dual Mobility Vivacit-E bearings because the size labels on the packages are swapped. Using the wrong size could lead to improper joint fit and surgical complications. Read more at govinfonow.com/recall/51193-zimmer-biomet-dual-mobility-vivacit-e-bearing-recall-size-mixup.

Source Summary by GovInfoNow · govinfonow.com/recall/51193-zimmer-biomet-dual-mobility-vivacit-e-bearing-recall-size-mixup · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0418-2026

Cite this page

“Zimmer Biomet Dual Mobility Vivacit-E Bearing Recall: Size Mixup Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51193-zimmer-biomet-dual-mobility-vivacit-e-bearing-recall-size-mixup. Based on FDA recall #Z-0418-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2026%22&limit=1).

The FDA announced on Sept. 26, 2025, that Zimmer, Inc. is recalling two lots of Zimmer Biomet Dual Mobility Vivacit-E bearings due to a commingle hazard where the implant size does not match the package label. The agency issued recall number Z-0418-2026 for the voluntary Class II action.

How to tell if you have it

  • Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing
  • Model/Catalog Number: 110031012
  • UPC: 00889024572706
  • Lot Numbers: 67160447 and others implied by 'two (2) lots'

The hazard

The recall addresses a commingle in which the outer package is labeled as one size but contains an implant of a different size. Specifically, packages labeled as Size F 44 mm may contain a Size G 46 mm implant, and vice versa.

Context

GovInfoNow's records show Zimmer, Inc. has 19 other recalls on record since Aug. 25, 2022. Recent brand recalls include the May 20, 2026 Off-Axis Alliance Glenoid Reamer Guide Recall for plastic guide breakage risk and the May 11, 2026 Persona Revision Femoral Distal Augment Recall involving a posterior augment found in the wrong package. Other recent recalls of similar products include the Feb. 16, 2026 EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up and the May 19, 2026 Howmedica Triathlon Baseplate Size 3 Recall for confusing labeling risk.

How to tell if you have this one

Check the package label for the size (F or G) and the implant dimensions (44 mm or 46 mm). The recall includes specific lot numbers and model numbers listed in the official notice.

  • Brand
    Zimmer
  • Product
    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing
  • 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: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
Recall numberProduct, codes & lotsQuantity
Z-0418-2026Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis; UDI (01)00889024572706(17)300406(10)67160447; Lot Number 6716044772 units
Z-0419-2026Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis; UDI (01)00889024572713(17)300406(10)67160480; Lot Number 6716048063 units
Based on the official FDA remedy

What to do — step by step

  1. Check Package Label

    Verify the size label on the package (F or G) and the corresponding implant dimensions (44 mm or 46 mm).

Where it went and when

Where it was distributed

Distributed in 20 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Florida, Georgia, Illinois, Iowa, Kansas, Maryland, Michigan, Nebraska, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Sep 26, 202512. FDA classified it Class II: Nov 3, 202523. Published in FDA’s Enforcement Report: Nov 12, 202532025
  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-0418-2026 (September 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0418-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 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