Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554

Recall date

January 10, 2020

Source

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

Recall number

Z-1383-2020

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

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

Why it was recalled

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

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 ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554