Biomet 3i, LLC recalls OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

Recall date

November 7, 2014

Source

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

Recall number

Z-1411-2015

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Tur…

Why it was recalled

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

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

What was recalled

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.