FDA recall Z-0079-2021

Product

CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-08-31

Report date

2020-10-14

Termination date

2022-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Beach Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2021