Biomet Healing Abutment May Cause Incorrect Rotation - Recall

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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 certain Healing Abutments that could cause incorrect rotation by about 30 degrees or misaligned margin contours. This could affect dental implants and requires correction to ensure proper fit.

Why it’s dangerous

The Healing Abutment may produce scanned data that rotates incorrectly by up to 30 degrees or misaligns the margin contour. This could lead to improper dental implant placement if not corrected.

Who’s affected

Dental patients with the recalled Healing Abutments are most at risk. The affected units are identified by specific lot numbers and reference codes.

How to tell if you have this one

Check for the model: 5MM(D) X 6MM(P) X 4MM(H) with reference number IEHA564. Affected units have lot numbers 1228628, 1230644, 1232164, 1232542, or 1232758.

Brand
Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot numbers and reference code on your Healing Abutment to confirm if it's affected.

✎ GovInfoNow

Questions people ask

What is the specific model of Healing Abutment being recalled?

The recalled model is 5MM(D) X 6MM(P) X 4MM(H) with reference number IEHA564.

Which lot numbers are affected?

Lot numbers 1228628, 1230644, 1232164, 1232542, and 1232758 are affected.

What should I do if I have the recalled Healing Abutment?

Check the lot numbers and reference code on your abutment to see if it's affected. If it is, contact Biomet for further instructions.

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-1385-2020 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-1385-2020 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-1385-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1385-2020 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 4MM(H) Reference Number: IEHA564

Lower-risk recall