Class II

Medical Device Recall: Plus Initial Drill, Article Number: 103.170;

Straumann USA LLC · April 14, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

288 units ($& US, 241 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1861-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.