BioHorizons TP3MU2LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236011963), received between Jul 31, 2023 and Aug 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K103691, K223697); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Fracture; Fracture

  THIS IS A SUMMARY REPORT FOR ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE ABUTMENT BREAKING OR BEING FRACTURED. THE REPORT WAS RECEIVED WITH NO PATIENT ADVERSE EVENT(S) BEING REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17432159 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  THIS IS A SUMMARY REPORT FOR FOUR (4) MALFUNCTION EVENTS. A REVIEW OF THE EVENT INVOLVED THE ABUTMENT BREAKING OR BEING FRACTURED. THE REPORT WAS RECEIVED WITH NO PATIENT ADVERS EVENT(S) BEING REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17431591 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103691, K223697. One submission often covers many models, so check the product and lot details in each record.

• Z-1111-2025 · Dec 6, 2024 · Open, Classified
  Temporary Titanium Abutments