Biomet 3i recalls certain Healing Abutments that may cause incorrect tooth rotation or margin misalignment during dental procedures. Affected units have specific lot numbers and reference codes.
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 3:1 recalls specific Healing Abutments that could cause incorrect tooth rotation or margin misalignment during dental procedures. This affects dental implants and requires checking the lot numbers listed in the recall.
The Healing Abutments may cause the dental implant to rotate incorrectly by about 30 degrees or misalign the margin contour during procedures. This could lead to improper tooth placement and potential complications.
Dental patients who have received the specific Healing Abutments with the listed lot numbers are affected. Dentists and dental technicians using these products are most at risk.
Check the product's reference number (IEHA454) and lot numbers: 1227498, 1228248, 1228639, 1228692, 1227504, 1228863, 1229535, 1229557, 1228807.
Verify the reference number (IEHA454) and lot numbers listed in the recall to confirm if your Healing Abutment is affected.
The Healing Abutments may cause incorrect rotation of about 30 degrees or margin contour misalignment during dental procedures.
Lot numbers 1227498, 1228248, 1228639, 1228692, 1227504, 1228863, 1229535, 1229557, and 1228807 are affected.
The recall does not specify a stop-use action; affected units should be checked against the listed lot numbers.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-1376-2020 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-1376-2020 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.
