Biomet 3i, LLC recalls Certain Micromini Flat Implant Cover Screw Dental implants

Recall date

November 25, 2015

Source

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

Recall number

Z-2488-2016

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, German…

Why it was recalled

Pouches may not have been sealed during packing.

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

What was recalled

Certain Micromini Flat Implant Cover Screw Dental implants