Biomet 3i 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 3i is recalling certain Healing Abutments that may cause incorrect rotation by up to 30 degrees during dental implant procedures. This could lead to misaligned margins and improper healing.

Why it’s dangerous

The Healing Abutments may produce scanned data that rotates incorrectly by about 30 degrees. This misalignment could cause improper tooth margin placement and affect the healing process after dental implant surgery.

Who’s affected

Dental patients who received the recalled Healing Abutments (lot numbers 1228701, 1230640, 1232762) are affected. Patients with dental implants using these specific units are most at risk.

How to tell if you have this one

Check for the reference number IEHA566 and lot numbers 1228701, 1230640, or 1232762 on the product packaging. The abutment dimensions are 5mm diameter x 6mm height x 6mm width.

Brand
Biomet 3i
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the reference number IEHA566 and lot numbers 1228701, 1230640, or 1232762 on the Healing Abutment packaging.

✎ GovInfoNow

Questions people ask

What is the specific problem with these Healing Abutments?

The recalled Healing Abutments may cause scanned data to rotate incorrectly by about 30 degrees, leading to margin contour misalignment during dental implant procedures.

Which lot numbers are affected?

Lot numbers 1228701, 1230640, and 1232762 are affected.

Do I need to do anything if I have this product?

The recall does not specify a remedy, so no action is required unless you have the affected lot numbers.

Take action

Contact Biomet 3i

We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1387-2020 — Biomet 3i Biomet 3i

Hello,

I own a Biomet 3i that is covered by recall Z-1387-2020 from Biomet 3i.

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-1387-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1387-2020 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 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

Lower-risk recall