Biomet recalls certain Bellatek Tin Abutment 5.0mm (Reference IEDAN5) due to manufacturing misalignment risk. Affected units 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 5.0mm dental implants because they were misaligned by 30 degrees during manufacturing. This misalignment could lead to improper placement in patients during dental procedures, potentially causing complications.
The abutments were manufactured 30 degrees misaligned compared to the patient's scan data. This misalignment can cause the abutment to not seat properly during dental procedures, potentially leading to improper placement and complications.
Dental professionals using the recalled Bellatek Tin Abutment 5.0mm implants are most at risk. Patients receiving these implants may experience improper placement if the abutment does not seat correctly.
Check for the Reference Number IEDAN5 on the product. Affected units have Lot Numbers 8560155-1, 8565718-1, 8565734-1, or 8569780-1. The UDI codes include the specific lot numbers listed.
Verify the Reference Number IEDAN5 and Lot Numbers 8560155-1, 8565718-1, 8565734-1, or 8569780-1 on the abutment.
The Bellatek Tin Abutments were manufactured 30 degrees misaligned compared to the patient's scan data, which could cause improper placement during dental procedures.
Check the product for the Reference Number IEDAN5 and Lot Numbers listed. If you have the affected units, contact Biomet for further instructions.
The recall is due to potential misalignment during placement, but the record does not specify a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0076-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0076-2021 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.
