FDA-Device2020-10-14Class II
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Biomet 3i, LLC
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
Sold states
FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Affected count
35 units
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2021Don't want to check this manually?
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