GM Helix Dental Implant
Straumann recalls GM Helix dental implants over a packaging label mismatch that could cause bone compression.
Do not use the implant if the implant inside the packaging does not match the information on the outer carton label. Contact Straumann USA LLC for instructions on returning the affected product.
Recall at a glance
- Quantity recalled
- 417 US
Why it was recalled
Straumann USA LLC is recalling the GM Helix Endosseous Dental Implant, Article No. 109.984, because the implant inside the packaging may not match the information on the outer carton label. If the incorrect implant is installed, it could cause bone compression or difficulty during installation even when there is sufficient bone volume.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Lot code
- MVXJ9
- UDI-DI
- 7899878024552
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Other recent recalls from Straumann USA LLC
Editorial summary by Recall Canary · summary updated 2026-08-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification