Official recall notice
FDA DeviceClass IINotable
GM Helix Implant Endosseous Dental Implant Recall (Aug 2026)
Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Recall date
- 2026-08-19
- Brand
- Straumann USA LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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
Product description
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
Affected products
UDI-DI 7899878024552 Lot MVXJ9