Biomet 3i recalls certain Healing Abutments with reference number IEHA344 due to potential 30-degree rotation error in dental implants. Affected lots include 1228885, 1229618, 1230155, and 1230308.
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 3i is recalling specific dental healing abutments that may cause incorrect rotation by up to 30 degrees during implant placement. This could lead to misaligned margins and improper healing. Affected units have reference number IEHA344 and specific lot numbers.
The healing abutment may produce scanned data that rotates incorrectly by about 30 degrees or misaligns the margin contour. This could cause improper implant placement and affect healing.
Dental patients who received the recalled healing abutments with reference number IEHA344 and lot numbers 1228885, 1229618, 1230155, or 1230308 are most at risk. These units are used in dental implant procedures.
Check for the reference number IEHA344 on the abutment packaging. The affected lot numbers are 1228885, 1229618, 1230155, and 1230308.
Verify the reference number IEHA344 and lot numbers 1228885, 1229618, 1230155, or 1230308 on the abutment.
The reference number is IEHA344.
Lot numbers 1228885, 1229618, 1230155, and 1230308 are affected.
The recall is for healing abutments used in dental implants that may cause incorrect rotation by up to 30 degrees, potentially leading to margin misalignment.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-1367-2020 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-1367-2020 from Biomet 3i. 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.
