Recall Z-2845-2016— Biomet 3i, LLC

Name: FDA recall Z-2845-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2016-08-08, terminated 2019-08-06. It names one FDA 510(k) clearance: K063341. Product: 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.. Reason: Product was incorrectly packaged..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2019-08-06
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K063341 — 3I OSSEOTITE CERTAIN DENTAL IMPLANTSImplant Innovations, Inc.·cleared 2007-04-30

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

3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.

Reason for recall

Product was incorrectly packaged.

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