Biomet recalls certain Healing Abutments (IEHA444) due to risk of 30-degree rotation error affecting dental implants. Affected units have specific lot numbers.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
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 treatment failure.
The Healing Abutments may produce scanned data that rotates dental implants by about 30 degrees. This misalignment could cause improper fit and treatment failure during dental procedures.
Dental patients who received the recalled Healing Abutments (lot numbers 1228625 or 1229564) are affected. Patients with dental implants using these specific abutments are most at risk.
Check for the product model: Bellatek Encode Healing Abutment 4.1mm x 4.1mm x 4mm. Look for lot numbers 1228625 or 1229564 on the packaging.
Look for lot numbers 1228625 or 1229564 on the Healing Abutment packaging.
The Healing Abutments may cause dental implants to rotate incorrectly by up to 30 degrees, leading to margin contour misalignment.
Check for lot numbers 1228625 or 1229564 on the packaging. The product model is Bellatek Encode Healing Abutment 4.1mm x 4.1mm x 4mm.
The recall does not specify a remedy, so contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1373-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1373-2020 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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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.