Has DePuy Mitek, Inc., a Johnson & Johnson Co. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to DePuy Mitek, Inc., a Johnson & Johnson Co.: 0 warning letters, 7 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 2023-06-14; 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

DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa…

Name: FDA Recall Record — DePuy Mitek, Inc., a Johnson & Johnson Co.
Creator: Argus HQ
Published: 2023-06-14
License: https://argushq.ai/methodology

Event date: 2023-06-14 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-1679-2023
Payload hash: 28b1e549b03ab0b5ec2a0d05…

Summary

IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentiall… Status: Ongoing.

Entities

DePuy Mitek, Inc., a Johnson & Johnson Co.

View source record ↗

Frequently asked questions

Has DePuy Mitek, Inc., a Johnson & Johnson Co. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to DePuy Mitek, Inc., a Johnson & Johnson Co.: 0 warning letters, 7 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 2023-06-14; 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 (2023). DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-depuy-mitek-inc-a-johnson-and-johnson-co-z-1679-2023

MLA

"DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-depuy-mitek-inc-a-johnson-and-johnson-co-z-1679-2023.

Chicago

Argus HQ Research. "DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-depuy-mitek-inc-a-johnson-and-johnson-co-z-1679-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_depuy_mitek_inc_a_johnson_and_johnson_co_z_1679_2023_2023,
  title = {DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-depuy-mitek-inc-a-johnson-and-johnson-co-z-1679-2023},
  note = {Accessed: July 23, 2026}
}

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