medical Class II Updated 2020-10-14

Biomet 3i, LLC recalls CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number

Recalled Product

CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

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: Lot Numbers: 8561074-1 8563880-1 8564060-1 8565449-1 8565945-1 8566616-1 8568052-1 8568808-1 8569206-1 8571880-1 UDI: (01)00844868031192(10)8561074-1 (01)00844868031192(10)8563880-1 (01)00844868031192(10)8564060-1 (01)00844868031192(10)8565449-1 (01)00844868031192(10)8565945-1 (01)00844868031192(10)8566616-1 (01)00844868031192(10)8568052-1 (01)00844868031192(10)8568808-1 (01)00844868031192(10)8569206-1 (01)00844868031192(10)8571880-1

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