Biomet 3i, LLC recalls BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured pro…

Recall date

September 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0835-2017

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(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