Biomet recalls certain Healing Abutments (IEHA443) due to potential 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 incorrect rotation during dental implant procedures. This could lead to misaligned dental work requiring additional corrections.
The Healing Abutment may produce scanned data that rotates incorrectly by about 30 degrees. This misalignment could cause dental implants to be placed in the wrong position, requiring additional procedures to correct.
Dental patients who received the recalled Healing Abutments (lot numbers 1227135 or 1228599) are affected. Dentists using these specific units for dental implants are at risk.
Check for the product name 'Bellatek Encode Healing Abutment' with dimensions 4.1mm x 4.1mm x 3mm. The reference number is IEHA443 and lot numbers 1227135 or 1228599.
Review the product's reference number and lot numbers to confirm if it's affected.
The Healing Abutments may produce scanned data that rotates incorrectly by about 30 degrees, causing margin contour misalignment.
Lot numbers 1227135 and 1228599.
Look for the reference number IEHA443 with dimensions 4.1mm x 4.1mm x 3mm and the specific lot numbers.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1372-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1372-2020 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.
