Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM Recalled by Biomet 3i, LLC Due to During manufacturing, the screw stop ledge was not...
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
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Quantity: 3 units
Why Was This Recalled?
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
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