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Lower risk Medical device recall · FDA · Published January 10, 2020

Biomet Healing Abutment Recall: Incorrect Rotation Risk

Biomet recalls certain Healing Abutments (IEHA353, Lot 1228667) due to potential 30-degree rotation error affecting dental implants. Affected users should contact Biomet for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1369-2020Medical deviceBiomet ›
Take action

Contact the company

Recalling firmBiomet 3i, LLC4555 Riverside Dr · Palm Beach Gardens, FL 33410-4200
✎ GovInfoNow plain-language explainer

Biomet is recalling specific Healing Abutments that may cause dental implants to rotate incorrectly by up to 30 degrees. This could lead to improper fit and complications during dental procedures. Read more at govinfonow.com/recall/66103-biomet-healing-abutment-recall-incorrect-rotation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66103-biomet-healing-abutment-recall-incorrect-rotation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1369-2020

Cite this page

“Biomet Healing Abutment Recall: Incorrect Rotation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66103-biomet-healing-abutment-recall-incorrect-rotation-risk. Based on FDA recall #Z-1369-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2020%22&limit=1).

The FDA announced on Jan. 10, 2020, that Biomet 3i, LLC voluntarily recalled certain Bellatek Encode Healing Abutments due to a hazard involving incorrect rotation and margin contour misalignment in resulting impression or scanned data.

How to tell if you have it

  • Brand: Biomet
  • Product: Bellatek Encode Healing Abutment 3.4MM(D) X 5MM(P) X 3MM(H)
  • Reference Number: IEHA353
  • Lot Numbers: 1228667

The hazard

According to the FDA, the recalled healing abutment lots result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment in the impression or scanned data produced from them.

Context

GovInfoNow's records show Biomet 3i, LLC has two other recalls on record since Feb. 26, 2019. On Aug. 31, 2020, the company recalled Bellatek Titanium Abutments due to a misalignment risk where the hex was misaligned by 30 degrees compared with patient scan data. On Feb. 26, 2019, Biomet 3i recalled Titanium Abutments because the screw stop ledge was not made to specification during manufacturing. Other recent recalls of similar products include Biomet Intramedullary Bone Saw Blade Recalls (July 1, 2026) and Straumann Dental Implant Abutments Recall (March 27, 2026).

How to tell if you have this one

Check for the model number IEHA353 and lot number 1228667 on the Healing Abutment. The product is a 3.4mm diameter x 5mm length x 3mm height implant component.

  • Brand
    Biomet
  • Category
    Medical device
FDA recall event · 23 products

All 23 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
    Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
Recall numberProduct, codes & lots
Z-1366-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343; Lot Numbers: 1228842, 1230153
Z-1367-2020CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344; Lot Numbers: 1228885 1229618 1230155 1230308
Z-1368-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346; Lot Numbers: 1228247
Z-1369-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353; Lot Numbers: 1228667
Z-1370-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354; Lot Numbers: 1228687, 1229554, 1229555
Z-1371-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356; Lot Numbers: 1228605
Z-1372-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443; Lot Numbers: 1227135, 1228599
Z-1373-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444; Lot Numbers: 1228625, 1229564
Z-1374-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446; Lot Numbers: 1228703
Z-1375-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453; Lot Numbers: 1228602
Z-1376-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454; Lot Numbers: 1227498 1228248 1228639 1228692 1227504 1228863 1229535 1229557 1228807
Z-1377-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456; Lot Numbers: 1229560
Z-1378-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463; Lot Numbers: 1228840
Z-1379-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464; Lot Numbers: 1229063 1229569
Z-1380-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466; Lot Numbers: 1228704
Z-1381-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474; Lot Numbers: 1228899
Z-1382-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553; Lot Numbers: 1228597 1228828 1230625
Z-1383-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554; Lot Numbers: 1228904 1230638
Z-1384-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563; Lot Numbers: 1228593 1230791
Z-1385-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564; Lot Numbers: 1228628 1230644 1232164 1232542 1232758
Z-1386-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564; Lot Numbers: 1228628 1230644 1232164 1232542 1232758
Z-1387-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566; Lot Numbers: 1228701 1230640 1232762
Z-1388-2020CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574; Lot Numbers: 1229061
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number (IEHA353) and lot number (1228667) on the Healing Abutment.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

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

1. Firm started the recall: Jan 10, 202012. FDA classified it Class II: Feb 26, 202023. Published in FDA’s Enforcement Report: Mar 4, 202034. FDA terminated the recall: Aug 2, 2021420202021
  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-1369-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2020 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