BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling BellaTek Titanium Abutment 4.1MM units (Reference Number: EDAT4) due to a manufacturing defect affecting the hex alignment. During production, the hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees compared to the patient scan data provided. This misalignment may prevent the definitive abutment from seating in the correct orientation when placed in the patient. Two units were affected and distributed across Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The recalled products include two specific lot numbers: Lot Number 8570638-1 (UDI: (01)00844868030911(10)8570638-1) and Lot Number 8572781-3 (UDI: (01)00844868030911(10)8572781-3). The source document does not specify a remedy or corrective action for affected consumers.
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: 2 units Lot/code info: Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1; 8572781-3 UDI: (01)00844868030911(10)8572781-3
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.