CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling certain BELLATEK Titanium Abutment 3.4MM dental implant components (Item Number IIAT3) distributed nationwide and internationally. During manufacturing, the screw stop ledge inside the abutment was not made to the correct specifications and location, which allows the screw head to seat deeper than intended without a positive stop to prevent over-tightening.
The recall affects six units across six specific lot numbers: 8441907-1, 8441907-2, 8441907-3, 8442367-1, 8439134A-3, and 8439134A-4. The recall notice does not specify a remedy or recommended consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide and Puerto Rico, Canada, and Australia Quantity: 6 units Lot/code info: Lot Numbers/UDI: 8441907-1/(01)00844868031284(10)8441907-1 8441907-2/(01)00844868031284(10)8441907-2 8441907-3/(01)00844868031284(10)8441907-3 8442367-1/(01)00844868031284(10)8442367-1 8439134A-3/(01)00844868031284(10)8439134A-3 8439134A-4/(01)00844868031284(10)8439134A-4
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.