Biomet 3i, LLC: Medical Device Recall in 2020 - (Recall #: Z-1387-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

Product Classification:

Class II

Date Initiated: January 10, 2020

Date Posted: March 4, 2020

Recall Number: Z-1387-2020

Event ID: 84771

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

Status: Terminated

Product Quantity: N/A

Code Information:

Lot Numbers: 1228701 1230640 1232762

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated