Has Straumann USA LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to Straumann USA LLC: 0 warning letters, 5 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 2026-09-23; Argus observed and indexed it on 2026-09-29.

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, REF: 109.984;

Name: FDA Recall Record — Straumann USA LLC
Creator: Argus HQ
Published: 2026-09-23
License: https://argushq.ai/methodology

Event date: 2026-09-23 00:00:00Z
Observed: 2026-09-29 04:20:36Z
Source ID: Z-3173-2026
Payload hash: 0739c47a69b309537038fb0b…

Summary

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. 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 5 total FDA actions tied to Straumann USA LLC: 0 warning letters, 5 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 2026-09-23; Argus observed and indexed it on 2026-09-29.
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, REF: 109.984;. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-straumann-usa-llc-z-3173-2026

MLA

"Straumann USA LLC — Class II recall: GM Helix Implant, REF: 109.984;." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-straumann-usa-llc-z-3173-2026.

Chicago

Argus HQ Research. "Straumann USA LLC — Class II recall: GM Helix Implant, REF: 109.984;." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-straumann-usa-llc-z-3173-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_straumann_usa_llc_z_3173_2026_2026,
  title = {Straumann USA LLC — Class II recall: GM Helix Implant, REF: 109.984;},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-straumann-usa-llc-z-3173-2026},
  note = {Accessed: September 29, 2026}
}

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