Recall Z-2459-2016— Biomet 3i, LLC

Name: FDA recall Z-2459-2016
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. It names one FDA 510(k) clearance: K891613. Product: DAL-RO Housing, Female Assembly 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

510(k) clearances named in this recall

1 on FDA's record

K891613 — OVERDENTURE ATTACHMENTImplant Innovations International, Inc.·cleared 1989-10-10

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

DAL-RO Housing, Female Assembly 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.