Class II

Medical Device Recall: GM Helix Implant, REF: 109.984;

Straumann USA LLC · August 12, 2026

Reason for Recall

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

Distribution

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;

States Affected

NATIONWIDE

Quantity Affected

216

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3173-2026

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.

Straumann USA LLC Medical Device Recall: GM Helix Implant, REF: 109.984; | SafeCheck