Recall Z-1376-2020— Biomet 3i, LLC

Name: FDA recall Z-1376-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-10

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2020-01-10, terminated 2021-08-02. It names one FDA 510(k) clearance: K072642. Product: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454. Reason: 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.

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-01-10
Terminated: 2021-08-02
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K072642 — BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTSBiomet 3i, Inc.·cleared 2007-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.