FDA recall Z-3173-2026

Straumann USA LLC · Class II · device

Product

GM Helix Implant, REF: 109.984;

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;