Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intende

Recalled August 14, 2019 · FDA recall Z-2140-2019 · Biomet 3i

Hazard

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. · FDA Class II

Units

3 units

Sold at

Nationwide and Puerto Rico, Canada, and Australia

Description

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.

Product

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

Manufacturer(s)

Biomet 3i, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →