Has Medtronic Sofamor Danek USA Inc had other FDA enforcement actions?

Yes. Argus HQ has recorded 35 total FDA actions tied to Medtronic Sofamor Danek USA Inc: 0 warning letters, 35 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 2023-04-12; Argus observed and indexed it on 2026-07-16.

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

Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303;…

Name: FDA Recall Record — Medtronic Sofamor Danek USA Inc
Creator: Argus HQ
Published: 2023-04-12
License: https://argushq.ai/methodology

Event date: 2023-04-12 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1331-2023
Payload hash: 3671a611cabad5d4f682e236…

Summary

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Status: Ongoing.

Entities

Medtronic Sofamor Danek USA Inc

View source record ↗

Frequently asked questions

Has Medtronic Sofamor Danek USA Inc had other FDA enforcement actions?: Yes. Argus HQ has recorded 35 total FDA actions tied to Medtronic Sofamor Danek USA Inc: 0 warning letters, 35 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 2023-04-12; Argus observed and indexed it on 2026-07-16.
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 (2023). Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Grafton DBF Inject:  a)	GRAFTON T50303 DBF INJECT 3CC, REF T50303;…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1331-2023

MLA

"Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Grafton DBF Inject:  a)	GRAFTON T50303 DBF INJECT 3CC, REF T50303;…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1331-2023.

Chicago

Argus HQ Research. "Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Grafton DBF Inject:  a)	GRAFTON T50303 DBF INJECT 3CC, REF T50303;…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1331-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_sofamor_danek_usa_inc_z_1331_2023_2023,
  title = {Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Grafton DBF Inject:  a)	GRAFTON T50303 DBF INJECT 3CC, REF T50303;…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1331-2023},
  note = {Accessed: July 23, 2026}
}

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