medical Class II Updated 2020-10-14

Biomet 3i, LLC recalls BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model

Recalled Product

BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

Hazard / Issue

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

Issued by

FDA

Affected States: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Lot/Code Info: Reference Number: 3DPMSER Lot Numbers: 8560249-1 8564285-1 8570989-1 Reference Number: 3DPMSERQ Lot Numbers: 8561588-1 8561591-1 8569150-1 8570607-1
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