FDA-Device2020-10-14Class II
CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
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
4 units
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2021Don't want to check this manually?
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