Biomet recalls certain Healing Abutments (IEHA464) due to potential 30-degree rotation error affecting dental implants. Affected units include 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 complications during dental procedures.
The Healing Abutment may produce scanned data that rotates dental implants by about 30 degrees. This misalignment can cause improper fit and potential complications during dental procedures.
Dental patients who received the recalled Healing Abutments (lot numbers 1229063 or 1229569) are affected. Patients with dental implants using these abutments are at risk.
Check for the reference number IEHA464 and lot numbers 1229063 or 1229569 on the abutment packaging. The product dimensions are 4.1mm diameter x 6mm length x 4mm height.
Look for the reference number IEHA464 and lot numbers 1229063 or 1229569 on the abutment packaging.
The recalled Healing Abutment has reference number IEHA464 and dimensions 4.1mm diameter x 6mm length x 4mm height.
The recall record does not specify a remedy, so no action is required beyond checking if your abutment matches the described lot numbers.
The error may cause the implant to rotate by up to 30 degrees, leading to margin contour misalignment and potential complications during dental procedures.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1379-2020 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.