Biomet recalls certain Bellatek Tin Abutment 4.1MM implants (Reference IEDAN4) due to manufacturing misalignment that may cause improper placement during dental procedures.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Biomet is recalling specific Bellatek Tin Abutment 4.1MM dental implants because they were manufactured 30 degrees misaligned with patient scan data. This could lead to improper seating in the jawbone during dental implant placement, potentially causing misalignment issues.
The abutments were manufactured 30 degrees misaligned compared to the patient's scan data. This misalignment can cause the abutment to not seat correctly in the jawbone during implant placement, potentially leading to improper fit and misalignment issues.
Dental patients who have received the specific Bellatek Tin Abutment 4.1MM implants with the listed lot numbers or reference codes. Patients with dental implants made from these recalled parts are most at risk.
Check for the Bellatek Tin Abutment 4.1MM with Reference Number IEDAN4. Look for the specific lot numbers listed: 8563336-1, 8563892-1, 8563910-1, 8565718-2, 8571887-1, 8571887-2, 8571887-3, 8572668-1, 8572668-2.
Review the lot numbers and reference codes on your implant to see if they match the recalled list.
The recall does not require immediate action. Check your implant details to see if it matches the recalled list.
The misalignment could cause improper seating in the jawbone during implant placement, potentially leading to misalignment issues.
Check the lot numbers and reference codes on your implant against the list provided in the recall notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0075-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0075-2021 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.
