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fda_recall · device_recall · high

Stryker Corporation — Class II recall: Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the fol…

Event date
2024-09-04 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2725-2024
Payload hash
ea6966803df363a70dd42cb8

Summary

Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical… Status: Completed.

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 2024-09-04; 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 Corporation — Class II recall: Stryker iBur 3.0mm Diamond Round, Distal Bend -  intended to cut bone in the fol…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-corporation-z-2725-2024
MLA
"Stryker Corporation — Class II recall: Stryker iBur 3.0mm Diamond Round, Distal Bend -  intended to cut bone in the fol…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-stryker-corporation-z-2725-2024.
Chicago
Argus HQ Research. "Stryker Corporation — Class II recall: Stryker iBur 3.0mm Diamond Round, Distal Bend -  intended to cut bone in the fol…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-corporation-z-2725-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_stryker_corporation_z_2725_2024_2024,
  title = {Stryker Corporation — Class II recall: Stryker iBur 3.0mm Diamond Round, Distal Bend -  intended to cut bone in the fol…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-corporation-z-2725-2024},
  note = {Accessed: July 23, 2026}
}

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