Medical Device Recall: GM Helix Acqua Implant, Article Number: 140.985
Straumann USA LLC · May 1, 2025
Reason for Recall
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
207 units (54 US, 153 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1863-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.