Recall Z-2594-2014— Biomet 3i, LLC

Name: FDA recall Z-2594-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-25

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2014-06-25, terminated 2014-09-23. It names one FDA 510(k) clearance: K072642. Product: BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.. Reason: Identifiers on the label are correct but the label has the incorrect color coding..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Terminated: 2014-09-23
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

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

Reason for recall

Identifiers on the label are correct but the label has the incorrect color coding.

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