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 2024-05-01; 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: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the…

Name: FDA Recall Record — Zimmer, Inc.
Creator: Argus HQ
Published: 2024-05-01
License: https://argushq.ai/methodology

Event date: 2024-05-01 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1608-2024
Payload hash: fb7d998286450ed2b12521fc…

Summary

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. 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 2024-05-01; 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: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-zimmer-inc-z-1608-2024

MLA

"Zimmer, Inc. — Class II recall: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-zimmer-inc-z-1608-2024.

Chicago

Argus HQ Research. "Zimmer, Inc. — Class II recall: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-zimmer-inc-z-1608-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_zimmer_inc_z_1608_2024_2024,
  title = {Zimmer, Inc. — Class II recall: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-zimmer-inc-z-1608-2024},
  note = {Accessed: July 17, 2026}
}

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