Biomet Healing Abutment Recall: Incorrect Rotation Risk

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Recalling firmBiomet 3i, LLC4555 Riverside Dr, N/A · Palm Beach Gardens, FL 33410-4200

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Biomet is recalling specific Healing Abutments that may cause incorrect rotation or margin contour misalignment during dental procedures. This could lead to improper tooth alignment if used without correction.

Why it’s dangerous

The Healing Abutment may produce scanned data that rotates incorrectly by about 30 degrees or misaligns the tooth margin. This could cause improper tooth positioning during dental procedures if not corrected.

Who’s affected

Dentists and dental clinics using the recalled Healing Abutments (model IEHA453, Lot 1228602) are affected. Patients receiving dental work with these abutments may be at risk of misaligned teeth.

How to tell if you have this one

Check for the model number IEHA453 and lot number 1228602 on the Healing Abutment. The product dimensions are 4.1mm diameter x 5mm length x 3mm height.

Brand
Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number (IEHA453) and lot number (1228602) on the Healing Abutment.

✎ GovInfoNow

Questions people ask

What is the specific model and lot number of the recalled Healing Abutments?

The recalled model is IEHA453 with lot number 1228602.

How does this recall affect dental procedures?

The incorrect rotation or margin contour misalignment could lead to improper tooth positioning if not corrected.

Do I need to stop using the Healing Abutment immediately?

The recall does not require immediate stop use; check the model and lot number first.

Take action

Contact Biomet

We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1375-2020 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-1375-2020 from Biomet.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1375-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1375-2020 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.

Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453

Lower-risk recall