FDA-Device2025-06-04Class II
GM Helix Acqua Implant, Article Number: 140.985
Straumann USA LLC
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
207 units (54 US, 153 OUS)
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
GM Helix Acqua Implant, Article Number: 140.985
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1863-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief