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Lower risk Medical device recall · FDA · Published May 28, 2019

Nobel Biocare Healing Abutments Recall: Wrong Size Implant Risk

Nobel Biocare recalls dental healing abutments with incorrect size that could cause improper fit during implant procedures. Affected units have specific reference and UDI numbers.

🇺🇸 FDA recall #Z-2250-2020Medical deviceNobel Biocare ›
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Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609
✎ GovInfoNow plain-language explainer

What happened, in plain English

Nobel Biocare is recalling dental healing abutments that were found to have the wrong size. This could lead to improper fit during dental implant procedures, potentially causing complications. Read more at govinfonow.com/recall/67865-nobel-biocare-healing-abutments-recall-wrong-size-implant-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67865-nobel-biocare-healing-abutments-recall-wrong-size-implant-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2250-2020

Cite this page

“Nobel Biocare Healing Abutments Recall: Wrong Size Implant Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67865-nobel-biocare-healing-abutments-recall-wrong-size-implant-risk. Based on FDA recall #Z-2250-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2020%22&limit=1).

Why it’s dangerous

The recalled abutments contain the wrong size, which could result in improper fit when used with dental implants. This might cause complications during the healing process or affect the implant's success.

Who’s affected

Dental patients who received the recalled healing abutments for temporary implant support. Patients with dental implants using this specific model are most at risk.

How to tell if you have this one

Check for the reference number 36644 and unique identifier 07332747034462 on the packaging. The product is a dental healing abutment used with dental implants for temporary support.

  • Brand
    Nobel Biocare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for reference number 36644 and unique identifier 07332747034462 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, Michigan, New York, Tennessee.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: May 28, 201912. FDA classified it Class II: Jun 3, 202023. Published in FDA’s Enforcement Report: Jun 10, 202034. FDA terminated the recall: Feb 9, 2021420192021
  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-2250-2020 (May 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2250-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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