Recall Z-2484-2016— Biomet 3i, LLC

Name: FDA recall Z-2484-2016
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: Certain Implant EP Twist Lock TM Coping 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

Certain Implant EP Twist Lock TM Coping 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.