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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Biomet 3i, LLC: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

Agency Publication Date: February 26, 2020
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Affected Products

Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343

Lot Numbers: 1228842, 1230153

Lot Numbers:
Numbers
Product: CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344

Lot Numbers: 1228885 1229618 1230155 1230308

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346

Lot Numbers: 1228247

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353

Lot Numbers: 1228667

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354

Lot Numbers: 1228687, 1229554, 1229555

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356

Lot Numbers: 1228605

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443

Lot Numbers: 1227135, 1228599

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444

Lot Numbers: 1228625, 1229564

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446

Lot Numbers: 1228703

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453

Lot Numbers: 1228602

Lot Numbers:
Numbers
Product: CERTAIN 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

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456

Lot Numbers: 1229560

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463

Lot Numbers: 1228840

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464

Lot Numbers: 1229063 1229569

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466

Lot Numbers: 1228704

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474

Lot Numbers: 1228899

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553

Lot Numbers: 1228597 1228828 1230625

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554

Lot Numbers: 1228904 1230638

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563

Lot Numbers: 1228593 1230791

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564

Lot Numbers: 1228628 1230644 1232164 1232542 1232758

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564

Lot Numbers: 1228628 1230644 1232164 1232542 1232758

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

Lot Numbers: 1228701 1230640 1232762

Lot Numbers:
Numbers
Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574

Lot Numbers: 1229061

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84771
Status: Resolved
Manufacturer: Biomet 3i, LLC
Manufactured In: United States

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.