CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling certain BellaTek Tin Abutment 5.0mm products due to a manufacturing defect in which the hex component was misaligned by 30 degrees compared to the patient scan data provided. This misalignment could prevent the definitive abutment from seating correctly when placed in the patient. The recall affects 4 units distributed across Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The affected products are identified by lot numbers 8560155-1, 8565718-1, 8565734-1, and 8569780-1. 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.
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: 4 units Lot/code info: Lot Numbers: 8560155-1 8565718-1 8565734-1 8569780-1 UDI: (01)00844868031154(10)8560155-1 (01)00844868031154(10)8565718-1 (01)00844868031154(10)8565734-1 (01)00844868031154(10)8569780-1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.