CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling one unit of a BellaTek Titanium Abutment 6.0mm (Lot Number 8562282-1) because the hex component was misaligned by 30 degrees during manufacturing compared to the patient scan data. This misalignment means the definitive abutment will not seat in the correct orientation when placed in the patient. The affected product was distributed to dental practices in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The recall notice does not specify a remedy or recommended action for affected consumers or healthcare providers.
Written by software from the official notice below. Not reviewed by a lawyer.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Reason for recall: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient Distribution: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA Quantity: 1 unit Lot/code info: Lot Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.