FDAFDA · Food and drugs·Recall number Z-2929-2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Published August 19, 2026 · Recall initiated: July 13, 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 may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Straumann USA LLC
- Distributor
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Lot
- UDI-DI 7899878024552 Lot MVXJ9
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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