Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 Recalled by Biomet 3i, LLC Due to Hex of the BellaTek Encode Definitive Abutments was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomet 3i, LLC directly.
Affected Products
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Quantity: 2 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 11 states: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
About Biomet 3i, LLC
Biomet 3i, LLC has 222 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report