Skip to main content

fda_recall · device_recall · high

Zimmer, Inc. — Class II recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim…

Event date
2024-11-13 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-0285-2025
Payload hash
132f0334a51e6b5c8ed273df

Summary

A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone,… Status: Ongoing.

Entities

Frequently asked questions

Has Zimmer, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 64 total FDA actions tied to Zimmer, Inc.: 0 warning letters, 64 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 2024-11-13; 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). Zimmer, Inc. — Class II recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-zimmer-inc-z-0285-2025
MLA
"Zimmer, Inc. — Class II recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-zimmer-inc-z-0285-2025.
Chicago
Argus HQ Research. "Zimmer, Inc. — Class II recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-zimmer-inc-z-0285-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_zimmer_inc_z_0285_2025_2024,
  title = {Zimmer, Inc. — Class II recall: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-zimmer-inc-z-0285-2025},
  note = {Accessed: July 17, 2026}
}

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