Biomet 3i, LLC recalls CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5

Recall date

August 31, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0076-2021

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5