Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353

Recalled March 4, 2020 · FDA recall Z-1369-2020 · Biomet 3i

Hazard

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 · FDA Class II

Units

N/A

Sold at

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

Description

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

Product

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353

Manufacturer(s)

Biomet 3i, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →