Has Howmedica Osteonics Corp. had other FDA enforcement actions?

Yes. Argus HQ has recorded 14 total FDA actions tied to Howmedica Osteonics Corp.: 0 warning letters, 14 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 2026-09-23; Argus observed and indexed it on 2026-09-29.

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

Howmedica Osteonics Corp. — Class II recall: TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT S…

Name: FDA Recall Record — Howmedica Osteonics Corp.
Creator: Argus HQ
Published: 2026-09-23
License: https://argushq.ai/methodology

Event date: 2026-09-23 00:00:00Z
Observed: 2026-09-29 04:20:37Z
Source ID: Z-3198-2026
Payload hash: c9da45a87dbe4811c76c8034…

Summary

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, f… Status: Ongoing.

Entities

Howmedica Osteonics Corp.

View source record ↗

Frequently asked questions

Has Howmedica Osteonics Corp. had other FDA enforcement actions?: Yes. Argus HQ has recorded 14 total FDA actions tied to Howmedica Osteonics Corp.: 0 warning letters, 14 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 2026-09-23; Argus observed and indexed it on 2026-09-29.
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 (2026). Howmedica Osteonics Corp. — Class II recall: TRIATHLON HINGE INSERT SIZE 4 11MM	  	5612-P-411  	  	  TRIATHLON HINGE INSERT S…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-howmedica-osteonics-corp-z-3198-2026

MLA

"Howmedica Osteonics Corp. — Class II recall: TRIATHLON HINGE INSERT SIZE 4 11MM	  	5612-P-411  	  	  TRIATHLON HINGE INSERT S…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-howmedica-osteonics-corp-z-3198-2026.

Chicago

Argus HQ Research. "Howmedica Osteonics Corp. — Class II recall: TRIATHLON HINGE INSERT SIZE 4 11MM	  	5612-P-411  	  	  TRIATHLON HINGE INSERT S…." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-howmedica-osteonics-corp-z-3198-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_howmedica_osteonics_corp_z_3198_2026_2026,
  title = {Howmedica Osteonics Corp. — Class II recall: TRIATHLON HINGE INSERT SIZE 4 11MM	  	5612-P-411  	  	  TRIATHLON HINGE INSERT S…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-howmedica-osteonics-corp-z-3198-2026},
  note = {Accessed: September 29, 2026}
}

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