Biomet recalls 3D-printed BellaTek Encode Abutments with model numbers 3DPMSER and 3DPMSERQ due to manufacturing misalignment that 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 3D-printed dental abutments that were misaligned by 30 degrees during manufacturing. This misalignment could cause the abutments to not seat correctly in the patient's mouth, potentially leading to improper dental work.
The abutments were manufactured 30 degrees off from the patient's scan data. This misalignment means the abutments may not fit properly in the mouth, causing improper dental placement and potentially requiring additional procedures.
Dental patients who received the recalled 3D-printed abutments with model numbers 3DPMSER or 3DPMSERQ. Dentists and dental technicians using these specific abutments are most at risk of improper placement.
Check for model numbers 3DPMSER or 3DPMSERQ on the abutments. The lot numbers listed are 8560249-1, 8564285-1, 8570989-1 for 3DPMSER and 8561588-1, 8561591-1, 8569150-1, 8570607-1 for 3DPMSERQ.
Identify if your abutments have model numbers 3DPMSER or 3DPMSERQ.
Inform your dentist about the recalled model numbers to determine if your abutments are affected.
The abutments were misaligned by 30 degrees during manufacturing compared to the patient's scan data, which could cause improper placement.
Model numbers 3DPMSER and 3DPMSERQ with specific lot numbers listed in the recall notice.
No, but you should contact your dentist to check if your abutments are affected and whether they need to be replaced.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0073-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0073-2021 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.