Straumann USA LLC — GM Helix Implant, REF: 109.984;

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — device enforcement reference
Source observed: 8/12/2026, 12:00:00 AM UTC
Source updated: 9/15/2026, 12:00:00 AM UTC
Location: Andover, MA, US
hazard: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: GM Helix Implant, REF: 109.984;
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;
event number: 99707
manufacturer: Straumann USA LLC
recall number: Z-3173-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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