Recall Z-2760-2015— Biomet 3i, LLC

Name: FDA recall Z-2760-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-29

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2015-07-29, terminated 2016-05-16. It names one FDA 510(k) clearance: K072642. Product: UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.. Reason: MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Terminated: 2016-05-16
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

UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.

Reason for recall

MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.

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