FDA-Device2025-06-04Class II
GM Helix Acqua Implant, Article Number: 140.984
Hazard
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.
Affected count
300 units (125 US, 175 OUS)
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
GM Helix Acqua Implant, Article Number: 140.984
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1862-2025More 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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