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Lower risk Medical device recall · FDA · Published November 2, 2023

Biomet Biolox Ceramic Option Head Zimmer 12/14 40mm +0 Recall: Incorrect Adapter

Biomet recalls Biolox Ceramic Option Head Zimmer 12/14 40mm +0 (Item 00-8777-040-02) due to incorrect adapter in packaging. The adapter with neck length M/+0 was shipped instead of S/-3.0, which may cause improper fit.

🇺🇸 FDA recall #Z-0570-2024Medical deviceBiomet ›
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Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Biomet is recalling Biolox Ceramic Option Head Zimmer 12/14 40mm +0 (Item 00-8777-040-02) because an incorrect adapter was shipped in the packaging. This could lead to improper fit if the adapter is not the correct size, but the recall does not indicate a safety hazard. Read more at govinfonow.com/recall/56964-biomet-biolox-ceramic-option-head-zimmer-12-14-40mm-0.

Source Summary by GovInfoNow · govinfonow.com/recall/56964-biomet-biolox-ceramic-option-head-zimmer-12-14-40mm-0 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0570-2024

Cite this page

“Biomet Biolox Ceramic Option Head Zimmer 12/14 40mm +0 Recall: Incorrect Adapter.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56964-biomet-biolox-ceramic-option-head-zimmer-12-14-40mm-0. Based on FDA recall #Z-0570-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0570-2024%22&limit=1).

The FDA announced on November 2, 2023, that Biomet, Inc. is recalling Biolox Ceramic Option Head Zimmer 12/14 40mm +0 units due to an incorrect adapter in the packaging. The hazard involves a wrong neck length which may affect device function.

How to tell if you have it

  • Brand: Biomet
  • Product: Biolox Ceramic Option Head Zimmer 12/14 40mm +0
  • Item Number: 00-8777-040-02
  • UDI-DI: 00889024430563
  • Lot Number: 3145300

The hazard

One product complaint reported an incorrect adapter in the packaging. The package contained an adapter with neck length M/+0 instead of the required S/-3.0. The difference may be recognized by the size indicator on the device.

Context

GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since February 28, 2018. Other recent recalls of similar products include Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), Biomet ZipT recall (September 23, 2025), and Biomet Juggerknot Mini Soft Anchors Recall (September 9, 2025). Other recent recalls of similar products include Zeiss Intrabeam Spherical Applicator 1.5 cm Recall (June 1, 2026), EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (February 16, 2026), and Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation recall (May 13, 2026).

How to tell if you have this one

Check for the product name 'Biolox Ceramic Option Head Zimmer 12/14 40mm +0' and item number 00-8777-040-02. The adapter should have a neck length indicator showing 'S' for the correct size.

  • Brand
    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
    Ongoing
  • Distribution
    US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Recall numberProduct, codes & lots
Z-0569-2024Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01; UDI-DI: 00889024430556; Lot Number: 3145299
Z-0570-2024Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02; UDI-DI: 00889024430563; Lot Number: 3145300
Based on the official FDA remedy

What to do — step by step

  1. Check Adapter Size

    Verify the adapter neck length indicator on the device; it should read 'S' for the correct size.

Where it went and when

Where it was distributed

Distributed in 9 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee, Texas.

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Nov 2, 202312. FDA classified it Class II: Dec 18, 202323. Published in FDA’s Enforcement Report: Dec 27, 202332023
  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-0570-2024 (November 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0570-2024 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.
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