Has Stryker Orthopaedics had other FDA enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Stryker Orthopaedics: 0 warning letters, 6 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 2024-06-05; 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 Orthopaedics — Class II recall: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…

Name: FDA Recall Record — Stryker Orthopaedics
Creator: Argus HQ
Published: 2024-06-05
License: https://argushq.ai/methodology

Event date: 2024-06-05 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1912-2024
Payload hash: 5e669f24842b96ba5bc15db2…

Summary

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to T… Status: Ongoing.

Entities

Stryker Orthopaedics

View source record ↗

Frequently asked questions

Has Stryker Orthopaedics had other FDA enforcement actions?: Yes. Argus HQ has recorded 6 total FDA actions tied to Stryker Orthopaedics: 0 warning letters, 6 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 2024-06-05; 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 (2024). Stryker Orthopaedics — Class II recall: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial  Knee…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-orthopaedics-z-1912-2024

MLA

"Stryker Orthopaedics — Class II recall: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial  Knee…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-stryker-orthopaedics-z-1912-2024.

Chicago

Argus HQ Research. "Stryker Orthopaedics — Class II recall: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial  Knee…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-orthopaedics-z-1912-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_stryker_orthopaedics_z_1912_2024_2024,
  title = {Stryker Orthopaedics — Class II recall: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial  Knee…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-orthopaedics-z-1912-2024},
  note = {Accessed: July 23, 2026}
}

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