Biomet 3i recalls specific titanium abutments (Reference IEDAT4) that may misalign during dental implant placement due to manufacturing errors.
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 misaligned by 30 degrees during manufacturing. This could cause improper placement in dental implants, potentially leading to complications.
The abutments were misaligned by 30 degrees during manufacturing compared to the patient's scan data. This misalignment can cause the abutment to not seat correctly when placed in the mouth, potentially leading to improper implant positioning.
Dental patients who have received the recalled titanium abutments (Reference IEDAT4) or are planning to use them for dental implants. Patients with implants using these specific abutments are most at risk.
Check for the Reference Number IEDAT4 and Lot Numbers listed (e.g., 8560281-1, 8560299-1, etc.) on the abutment packaging or documentation. The UDI (Unique Device Identifier) codes also include these specific lot numbers.
Look for the Reference Number IEDAT4 and Lot Numbers listed in the recall notice on the abutment packaging or documentation.
The recalled abutments are the Bellatek Titanium Abutment 4.1MM with Reference Number IEDAT4.
Check for the Reference Number IEDAT4 and Lot Numbers listed (e.g., 8560281-1, 8560299-1, etc.) on the abutment packaging or documentation.
The recall notice does not specify a remedy, so contact your dentist to discuss potential next steps.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-0077-2021 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-0077-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
