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Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
Recalled June 4, 2025 · FDA recall Z-1862-2025 · Straumann USA
Hazard
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. · FDA Class II
Units
300 units (125 US, 175 OUS)
Sold at
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.
Description
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Product
GM Helix Acqua Implant, Article Number: 140.984
Manufacturer(s)
Straumann USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →