Official recall notice
FDA DeviceClass IINotable
FDA Recall: 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
Recommended action
What to do
417 US
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