FDA-Device2025-06-04Class II
Plus Initial Drill, Article Number: 103.170;
Straumann USA LLC
Hazard
The referred batch was produced without the laser engraving of 7 mm.
Sold states
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.
Affected count
288 units ($& US, 241 OUS)
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Plus Initial Drill, Article Number: 103.170;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1861-2025Don't want to check this manually?
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