Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984

Recall date

May 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1862-2025

FDA classification

Class II

Brand / firm

Straumann USA LLC

Sold / distributed

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, Un…

Why it was recalled

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GM Helix Acqua Implant, Article Number: 140.984