Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN
Recalled Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Hazard / Issue
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.
Issued by
FDA
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