Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intend…

Recall date

February 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2143-2019

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

Nationwide and Puerto Rico, Canada, and Australia

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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