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: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…

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 04:20:39Z
Source ID: Z-2935-2026
Payload hash: 370bdd654c76e3b02e12c2a0…

Summary

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. 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: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2935-2026

MLA

"Straumann USA LLC — Class II recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-straumann-usa-llc-z-2935-2026.

Chicago

Argus HQ Research. "Straumann USA LLC — Class II recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2935-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_straumann_usa_llc_z_2935_2026_2026,
  title = {Straumann USA LLC — Class II recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-straumann-usa-llc-z-2935-2026},
  note = {Accessed: August 27, 2026}
}

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