Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;

Recall date

April 14, 2025

Source

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

Recall number

Z-1861-2025

FDA classification

Class II

Brand / firm

Straumann USA LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine.

Why it was recalled

The referred batch was produced without the laser engraving of 7 mm.

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

What was recalled

Plus Initial Drill, Article Number: 103.170;