Straumann USA LLC: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Straumann USA LLC
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Reason / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-07-13
- Code info
- UDI-DI 7899878024552 Lot MVXJ9
- Product quantity
- 417 US
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 99407
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