Biomet recalls certain Healing Abutments (IEHA463, Lot 1228840) due to potential 30-degree rotation error affecting dental implants. Affected users should contact Biomet for details.
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 complications during dental procedures.
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.
Dental patients who received the recalled Healing Abutments (model IEHA463, Lot 1228840) during procedures. Patients with implants using this specific part are most at risk.
Check for the model number IEHA463 and lot number 1228840 on the Healing Abutment. The product dimensions are 4.1mm diameter x 6mm length x 3mm height.
Look for the model number IEHA463 and lot number 1228840 on the Healing Abutment.
The recalled model is IEHA463 with lot number 1228840.
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.
Contact Biomet directly for details about your specific product and next steps.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1378-2020 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.
