Official recall record
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-13
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 7899878024552
- Brand on record
- Straumann USA LLC
- Product category
- Medical Device
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-08-12 · US FDA — Medical Devices
GM Helix Implant, REF: 109.984;
Other recalls from this brand
- 2026-03-17 · US FDA — Medical Devices
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
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