Biomet 3i recalls specific titanium abutments (Reference Number IEDAT5) that may misalign during placement, risking incorrect patient fit. Affected units include specific lot numbers.
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 3i is recalling certain titanium abutments that were manufactured with a 30-degree misalignment compared to patient scan data. This could cause improper seating during dental procedures, potentially leading to incorrect placement and complications.
The abutments were produced with a 30-degree misalignment relative to the patient's scan data. This means they won't seat correctly during implant placement, potentially causing improper fit, discomfort, or complications.
Dental professionals using the recalled abutments for dental implants are most at risk. Patients receiving these implants may experience improper fit or complications due to the misalignment.
Check for the Reference Number IEDAT5 on the abutment packaging. Affected units include specific lot numbers: 8561074-1 through 8571880-1.
Look for the Reference Number IEDAT5 and specific lot numbers listed in the recall notice.
The recalled abutment is the Bellatek Titanium Abutment 5.0MM with Reference Number IEDAT5.
Check for the Reference Number IEDAT5 and specific lot numbers: 8561074-1 through 8571880-1.
The recall notice does not specify a remedy, so contact Biomet 3i directly for guidance.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-0078-2021 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-0078-2021 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.
