Has Stryker Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 89 total FDA actions tied to Stryker Corporation: 0 warning letters, 89 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 2023-09-27; 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

Stryker Corporation — Class II recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,…

Name: FDA Recall Record — Stryker Corporation
Creator: Argus HQ
Published: 2023-09-27
License: https://argushq.ai/methodology

Event date: 2023-09-27 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2602-2023
Payload hash: a6e5f95f114ca87327034850…

Summary

Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site Status: Ongoing.

Entities

Stryker Corporation

View source record ↗

Frequently asked questions

Has Stryker Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 89 total FDA actions tied to Stryker Corporation: 0 warning letters, 89 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 2023-09-27; 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). Stryker Corporation — Class II recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-corporation-z-2602-2023

MLA

"Stryker Corporation — Class II recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-stryker-corporation-z-2602-2023.

Chicago

Argus HQ Research. "Stryker Corporation — Class II recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-corporation-z-2602-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_stryker_corporation_z_2602_2023_2023,
  title = {Stryker Corporation — Class II recall: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle,…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-corporation-z-2602-2023},
  note = {Accessed: July 23, 2026}
}

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