Biomet recalls certain Healing Abutments that may cause incorrect rotation by 30 degrees, leading to margin contour misalignment. Affected units include 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 is recalling certain Healing Abutments that can cause incorrect rotation by about 3:00 degrees and margin misalignment. This could affect dental implants and requires attention to avoid complications.
The Healing Abutment may produce scanned data that rotates incorrectly by up to 30 degrees or misaligns the margin contour. This can lead to improper implant placement and potential complications during dental procedures.
Dental patients who have the specific lot numbers listed (1228628, 1230644, etc.) or the reference number IEHA564. Patients with dental implants using these abutments are most at risk.
Check the product label for the reference number IEHA564 and lot numbers 1228628, 1230644, 1232164, 1232542, or 1232758. The abutment dimensions are 5mm diameter x 6mm height x 4mm thickness.
Look for the reference number IEHA564 and lot numbers listed (1228628, 1230644, 1232164, 1232542, 1232758).
The Healing Abutment may cause incorrect rotation by up to 30 degrees or margin contour misalignment, which could affect dental implant placement.
Check the product label for the reference number IEHA564 and lot numbers 1228628, 1230644, 1232164, 1232542, or 1232758.
The recall does not specify a remedy, so contact Biomet directly for guidance on 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-1386-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1386-2020 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.
