Straumann USA LLC — GM Helix Implant, Endosseous Dental Implant Article No. 109.984
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 13, 2026
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.
What's affected?
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Brand
- Straumann USA LLC
- Lot code
- MVXJ9
Additional details
UDI-DI 7899878024552 Lot MVXJ9
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 417 US.
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