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
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling certain BELLATEK Tin Abutment 3.4MM products (Item Number IEDAN3) used as accessories for dental implants. A total of 3 units were distributed nationwide and in Puerto Rico, Canada, and Australia. The products were recalled because during manufacturing, the screw stop ledge was not made to specification and location within the abutment, which resulted in the screw head seating deeper in the abutment with no positive stop.
The affected lot numbers are 8442784-1, 8442469-1, and 8442689-1. The source document does not specify what actions an affected consumer should take.
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: 3 units Lot/code info: Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.