TemporaryFDAOngoing
Can cause harm that is usually temporary.
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Check the device or its packaging for
UDI-DI 7899878024552 Lot MVXJ9
- Why
- 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
- Distributed
- 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.
- Company
- Straumann USA LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2929-2026 · retrieved 10 August 2026
Read the official notice