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 dental implants to rotate incorrectly by about 30 degrees. This could lead to improper alignment and affect the implant's success.

Why it’s dangerous

The Healing Abutments may produce scanned data that rotates the dental implant by about 30 degrees. This misalignment could cause improper fit and affect the implant's long-term success.

Who’s affected

Dental patients who have received the recalled Healing Abutments (4.1mm x 7.5mm x 4mm) with lot number 1228899. Patients with dental implants using these abutments are most at risk.

How to tell if you have this one

Check if your Healing Abutment has dimensions 4.1mm (diameter) x 7.5mm (height) x 4mm (depth) and lot number 1228899. The reference number is IEHA474.

Brand
Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your Healing Abutment's dimensions and lot number to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The Healing Abutments may cause dental implants to rotate incorrectly by about 30 degrees, which could affect their alignment and success.

How do I know if my abutment is affected?

Check if your Healing Abutment has dimensions 4.1mm x 7.5mm x 4mm and lot number 1228899.

What should I do if I have the affected abutment?

The recall does not require immediate action; check your product details to confirm if it's affected.

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-1381-2020 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-1381-2020 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-1381-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1381-2020 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 7.5MM(P) X 4MM(H) Reference Number: IEHA474

Lower-risk recall