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fda_recall · device_recall · high

Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…

Event date
2025-06-18 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1914-2025
Payload hash
f7480e2059c7edf780efd2fd

Summary

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. Status: Ongoing.

Entities

Frequently asked questions

Has Stryker GmbH had other FDA enforcement actions?
Yes. Argus HQ has recorded 9 total FDA actions tied to Stryker GmbH: 0 warning letters, 9 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 2025-06-18; 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 (2025). Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-gmbh-z-1914-2025
MLA
"Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-stryker-gmbh-z-1914-2025.
Chicago
Argus HQ Research. "Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-gmbh-z-1914-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_stryker_gmbh_z_1914_2025_2025,
  title = {Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-gmbh-z-1914-2025},
  note = {Accessed: July 23, 2026}
}

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