Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of si…

Recall date

March 3, 2017

Source

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

Recall number

Z-2551-2018

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.

Why it was recalled

The main vial label lists the incorrect part number, but the cap label is correct.

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

What was recalled

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.