FDA recall Z-1375-2020

Product

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453

Reason for recall

Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

Distribution

Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

Key facts

Status

Terminated

Initiation date

2020-01-10

Report date

2020-03-04

Termination date

2021-08-02

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-1375-2020