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 Bellatek Titanium Abutment 4.1mm Recall: Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64391-biomet-bellatek-titanium-abutment-4-1mm-recall-misalignment-risk. Based on FDA recall #Z-0074-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2021%22&limit=1).
The FDA announced on August 31, 2020, that Biomet 3i, LLC voluntarily recalled BELLATEK TITANIUM ABUTMENT 4.1MM units due to a manufacturing defect. The hazard involves misaligned hexes that prevent the abutment from seating in the correct orientation.
Distribution: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
The hazard
The hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing compared with provided patient scan data. This defect causes the definitive abutment to not seat in the correct orientation upon attempted placement.
Context
GovInfoNow's records show Biomet 3i, LLC has two other recalls on record since February 26, 2019. On January 10, 2020, the company recalled Healing Abutments due to incorrect rotation risk. Other recent recalls of similar products include Straumann Custom Abutment AS Ti Recall (March 17, 2026), Straumann Custom Abutment Ti Recall (March 17, 2026), and Straumann Dental Implant Abutments Recall (March 27, 2026).
How to tell if you have this one
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.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Recall number
Product, codes & lots
Quantity
Z-0073-2021
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ; Reference Number: 3DPMSER Lot Numbers: 8560249-1 8564285-1 8570989-1 Reference Number: 3DPMSERQ Lot Numbers: 8561588-1 8561591-1 8569150-1 8570607-1
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.
Official source: FDA Recall #Z-0074-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.