CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Check against the official notice below — it lists the full affected range.
Biomet 3i, LLC is recalling certain BellaTek Titanium Abutment 4.1mm devices because the hex connector 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's mouth. A total of 35 units across 36 lot numbers have been distributed to dental facilities in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.
The recall notice does not specify what action affected consumers or their dental providers should take in response to this recall.
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: 35 units Lot/code info: Lot Numbers: 8560281-1 8560299-1 8561332-3 8561476-1 8563315-1 8564057-1 8564060-3 8564060-4 8564064-1 8564524-1 8564524-2 8565357-1 8565414-3 8566637-1 8566637-2 8566648-1 8566969-2 8567559-1 8567578-1 8568041-1 8568705-1 8568819-1 8569841-7 8569987-1 8570625-1 8570737-1 8571824-1 8571843-1 8571850-1 8571866-1 8571887-4 8571887-5 8572228-1 8572238-1 8572238-2 UDI: (01)00844868031185(10)8560281-1 (01)00844868031185(10)8560299-1 (01)00844868031185(10)8561332-3 (01)00844868031185(10)8561476-1 (01)00844868031185(10)8563315-1 (01)00844868031185(10)8564057-1 (01)00844868031185(10)8564060-3 (01)00844868031185(10)8564060-4 (01)00844868031185(10)8564064-1 (01)00844868031185(10)8564524-1 (01)00844868031185(10)8564524-2 (01)00844868031185(10)8565357-1 (01)00844868031185(10)8565414-3 (01)00844868031185(10)8566637-1 (01)00844868031185(10)8566637-2 (01)00844868031185(10)8566648-1 (01)00844868031185(10)8566969-2 (01)00844868031185(10)8567559-1 (01)00844868031185(10)8567578-1 (01)00844868031185(10)8568041-1 (01)00844868031185(10)8568705-1 (01)00844868031185(10)8568819-1 (01)00844868031185(10)8569841-7 (01)00844868031185(10)8569987-1 (01)00844868031185(10)8570625-1 (01)00844868031185(10)8570737-1 (01)00844868031185(10)8571824-1 (01)00844868031185(10)8571843-1 (01)00844868031185(10)8571850-1 (01)00844868031185(10)8571866-1 (01)00844868031185(10)8571887-4 (01)00844868031185(10)8571887-5 (01)00844868031185(10)8572228-1 (01)00844868031185(10)8572238-1 01)00844868031185(10)8572238-2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.