Home / Recalls / Medical Devices
Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;
Recalled June 4, 2025 · FDA recall Z-1861-2025 · Straumann USA
Hazard
The referred batch was produced without the laser engraving of 7 mm. · FDA Class II
Units
288 units ($& US, 241 OUS)
Sold at
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.
Description
The referred batch was produced without the laser engraving of 7 mm.
Product
Plus Initial Drill, Article Number: 103.170;
Manufacturer(s)
Straumann USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →