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 2023-05-17; 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: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, L…

Name: FDA Recall Record — Medtronic Sofamor Danek USA Inc
Creator: Argus HQ
Published: 2023-05-17
License: https://argushq.ai/methodology

Event date: 2023-05-17 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1574-2023
Payload hash: 017eb152599b853336518dca…

Summary

Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor. 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 2023-05-17; 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: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, L…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1574-2023

MLA

"Medtronic Sofamor Danek USA Inc — Class II recall: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, L…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1574-2023.

Chicago

Argus HQ Research. "Medtronic Sofamor Danek USA Inc — Class II recall: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, L…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1574-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_sofamor_danek_usa_inc_z_1574_2023_2023,
  title = {Medtronic Sofamor Danek USA Inc — Class II recall: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, L…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-sofamor-danek-usa-inc-z-1574-2023},
  note = {Accessed: July 23, 2026}
}

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