Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens Recalled by Biomet 3i, LLC Due to Reports relating to Biomet 3i's BellaTek Zirconia Dental...
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
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
Quantity: 10,454
Why Was This Recalled?
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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