Recall Z-0845-2017— Biomet 3i, LLC

Name: FDA recall Z-0845-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-14

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2016-09-14, terminated 2019-07-26. It names one FDA 510(k) clearance: K092341. Product: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Reason: A limited number of product pouches may not have been sealed during packaging..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-09-14
Terminated: 2019-07-26
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K092341 — LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTIONBiomet 3i, Inc.·cleared 2009-11-30

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

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Reason for recall

A limited number of product pouches may not have been sealed during packaging.

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