Recall Z-2454-2016— Biomet 3i, LLC

Name: FDA recall Z-2454-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2015-11-25, terminated 2019-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Conical EP Pick-Up Coping (Non-Hexed) Dental implants. Reason: Pouches may not have been sealed during packing..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2019-07-26
Firm location: Palm Beach Gardens, FL, United States

Product description

Conical EP Pick-Up Coping (Non-Hexed) Dental implants

Reason for recall

Pouches may not have been sealed during packing.

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