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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The recalled Healing Abutments may cause dental implants to rotate incorrectly by up to 30 degrees. This misalignment can lead to improper fit and potential complications during dental procedures.

Who’s affected

Dental patients who have received the recalled Healing Abutments (model IEHA353, Lot 1228667) are affected. Patients with dental implants using this specific product are most at risk.

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

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled Healing Abutment?

The recalled model number is IEHA353.

What lot number is affected by this recall?

Lot number 1228667 is affected.

How does this recall affect dental implants?

The recall involves Healing Abutments that may cause dental implants to rotate incorrectly by up to 30 degrees, potentially leading to improper fit and complications.

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-1369-2020 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-1369-2020 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-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.

Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353

Lower-risk recall