FDAFDA · Food and drugs·Recall number Z-3173-2026
GM Helix Implant, REF: 109.984;
Published September 23, 2026 · Recall initiated: August 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Straumann USA LLC
- Distributor
- 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;
- Lot
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.