FDA-Device2025-06-04Class II
Plus Initial Drill, Article Number: 103.170;
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-1861-2025More Straumann USA LLC recalls
- FDA-Device2026-04-01Straumann Custom Abutment Ti recalled for incorrect material composition
- FDA-Device2026-04-01Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
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