Biomet recalls Bellatek Titanium Abutment 4.1mm (EDAT4) due to manufacturing misalignment risk. This 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 Bellatek Titanium Abutments 4.1mm (Reference Number EDAT4) because they were misaligned by 30 degrees during manufacturing. This misalignment could lead to improper placement in dental procedures, potentially causing complications.
The abutments were misaligned by 30 degrees during manufacturing compared to the patient's scan data. This misalignment means the abutment may not seat correctly when placed in the patient's jaw, potentially causing improper implant positioning.
Dental professionals who use the recalled Bellatek Titanium Abutments 4.1mm (EDAT4) for dental implants. Patients receiving dental implants with these abutments are at risk of improper placement.
Check for the Reference Number EDAT4 on the abutment packaging. Lot numbers 8570638-1 and 8572781-3 are associated with this recall. The UDI (Unique Device Identifier) starts with (01)00844868030911(10) followed by the lot number.
Look for the Reference Number EDAT4 and Lot Numbers 8570638-1 or 8572781-3 on the abutment packaging.
The abutments were misaligned by 30 degrees during manufacturing compared to the patient's scan data, which could lead to improper placement during dental procedures.
Check for the Reference Number EDAT4 and Lot Numbers 8570638-1 or 8572781-3 on the abutment packaging. The UDI starts with (01)00844868030911(10) followed by the lot number.
The recall record does not specify a remedy, so contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0074-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0074-2021 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.
