Biomet 3i, LLC: CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

Is my product affected?

CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

• UPC 00844868031147

Check against the official notice below — it lists the full affected range.

What happened

Biomet 3i, LLC is recalling certain BellaTek Encode Definitive Abutments (4.1mm) due to a manufacturing defect affecting nine units. The hex component of these abutments was misaligned by 30 degrees compared to the patient scan data provided, which means the abutment will not seat correctly in the proper orientation when a dental professional attempts to place it in the patient.

The affected abutments were distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia. The recalled lot numbers are 8563336-1, 8563892-1, 8563910-1, 8565718-2, 8571887-1, 8571887-2, 8571887-3, 8572668-1, and 8572668-2. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 9 units Lot/code info: Lot Numbers: 8563336-1 8563892-1 8563910-1 8565718-2 8571887-1 8571887-2 8571887-3 8572668-1 8572668-2 UDI: (01)00844868031147(10)8563336-1 (01)00844868031147(10)8563892-1 (01)00844868031147(10)8563910-1 (01)00844868031147(10)8565718-2 (01)00844868031147(10)8571887-1 (01)00844868031147(10)8571887-2 (01)00844868031147(10)8571887-3 (01)00844868031147(10)8572668-1 (01)00844868031147(10)8572668-2

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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