Biomet 3i Recalls Healing Abutment Due to 30-Degree Rotation Error

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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 specific Healing Abutment implants that can cause incorrect rotation by about 30 degrees during dental procedures. This error may lead to misaligned tooth margins and improper treatment outcomes.

Why it’s dangerous

The recalled Healing Abutments may cause a 30-degree rotation error when scanned or imprinted, leading to misaligned tooth margins. This can affect the accuracy of dental procedures and potentially cause treatment complications.

Who’s affected

Dental patients who received the recalled Healing Abutment implants (reference number IEHA554) with lot numbers 1228904 or 1230638. Patients using these implants for dental procedures are most at risk.

How to tell if you have this one

Check for the reference number IEHA554 on the implant packaging. Look for lot numbers 1228904 or 1230638 on the implant or its packaging.

Brand
Biomet 3i
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Implant Details
Verify the reference number and lot numbers on the implant packaging to determine if it is recalled.

✎ GovInfoNow

Questions people ask

Do I need to stop using the implant immediately?

The recall does not require immediate discontinuation; check the reference number and lot numbers to confirm if it is recalled.

What should I do if I have the recalled implant?

Contact Biomet 3i directly to confirm if your implant is recalled and follow their instructions.

How can I tell if my implant is part of this recall?

Look for the reference number IEHA554 and lot numbers 1228904 or 1230638 on the implant packaging.

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-1383-2020 — Biomet 3i Biomet 3i

Hello,

I own a Biomet 3i that is covered by recall Z-1383-2020 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-1383-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1383-2020 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 5.6MM(P) X 4MM(H) Reference Number: IEHA554

Lower-risk recall