Has Straumann USA LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Straumann USA LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-19; Argus observed and indexed it on 2026-08-26.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Name: FDA Recall Record — Straumann USA LLC
Creator: Argus HQ
Published: 2026-08-19
License: https://argushq.ai/methodology

Event date: 2026-08-19 00:00:00Z
Observed: 2026-08-26 04:20:40Z
Source ID: Z-2929-2026
Payload hash: 24b6750c5cabe6206ef62c6a…

Summary

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 Status: Ongoing.

Entities

Straumann USA LLC

View source record ↗

Frequently asked questions

Has Straumann USA LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Straumann USA LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-19; Argus observed and indexed it on 2026-08-26.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant  Article No. 109.984. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2929-2026

MLA

"Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant  Article No. 109.984." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-straumann-usa-llc-z-2929-2026.

Chicago

Argus HQ Research. "Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant  Article No. 109.984." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2929-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_straumann_usa_llc_z_2929_2026_2026,
  title = {Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant  Article No. 109.984},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2929-2026},
  note = {Accessed: August 27, 2026}
}

Informational only. Not legal, financial, or medical advice.