Biomet recalls certain Bellatek Titanium Abutment 6.0mm (Reference IEDAT6) due to manufacturing misalignment risk causing 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 Titanium Abutments that may be misaligned by 30 degrees during manufacturing. This could lead to improper placement in dental procedures, potentially causing complications for patients.
The abutments were manufactured 30 degrees misaligned compared to patient scan data. This misalignment could cause the abutment to not seat correctly during dental procedures, potentially leading to complications.
Dental professionals using the recalled Bellatek Titanium Abutments (6.0mm, Reference IEDAT6) are affected. Patients receiving dental procedures with these abutments may be at risk of improper placement.
Check for the Reference Number IEDAT6 and Lot Number 8562282-1 on the abutment packaging. The UDI code (01)00844868031208(10)8562282-1 is also associated with this recall.
Verify the Reference Number IEDAT6 and Lot Number 8562282-1 on the abutment packaging.
The Bellatek Titanium Abutments were manufactured 30 degrees misaligned compared to patient scan data, which could cause improper placement during dental procedures.
Check the product for Reference Number IEDAT6 and Lot Number 8562282-1. If you have these details, contact Biomet for further instructions.
The recall indicates a potential for improper placement, but the official notice does not specify a risk of serious injury or death.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0079-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0079-2021 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.
