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
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling certain BELLATEK Tin Abutment 3.4MM dental implant components (Item Number ILDAN3) due to a manufacturing defect. During production, the screw stop ledge was not made to specification and proper location within the abutment, which allows the screw head to seat deeper than intended without a positive stop to prevent over-tightening. The recall affects 2 units distributed nationwide and in Puerto Rico, Canada, and Australia, specifically Lot Numbers 8442561-2 and 8442561-3.
The source document does not specify a remedy or recommended action for affected consumers.
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: 2 units Lot/code info: Lot Numbers/UDI: 8442561-2/(01)00844868031352(10)8442561-2 8442561-3/(01)00844868031352(10)8442561-3
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.