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 2025-12-31; 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

Zimmer, Inc. — Class II recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg…

Name: FDA Recall Record — Zimmer, Inc.
Creator: Argus HQ
Published: 2025-12-31
License: https://argushq.ai/methodology

Event date: 2025-12-31 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0980-2026
Payload hash: dad64c8bb705f1fd620f7f42…

Summary

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical… Status: Ongoing.

Entities

Zimmer, Inc.

View source record ↗

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 2025-12-31; 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). Zimmer, Inc. — Class II recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-zimmer-inc-z-0980-2026

MLA

"Zimmer, Inc. — Class II recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-zimmer-inc-z-0980-2026.

Chicago

Argus HQ Research. "Zimmer, Inc. — Class II recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-zimmer-inc-z-0980-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_zimmer_inc_z_0980_2026_2025,
  title = {Zimmer, Inc. — Class II recall: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Anteg…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-zimmer-inc-z-0980-2026},
  note = {Accessed: July 17, 2026}
}

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