Digitex 52031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932504010), received between Apr 20, 2016 and Apr 20, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120284); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2016Device Slipped; Device Or Device Fragments Location Unknown; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, PHYSICIAN PASSED THE SUTURE THROUGH THE SSL AND UPON PLACEMENT PHYSICIAN DIDN'T LIKE THE POSITION OF THE SUTURE AND WENT TO PULL THE SUTURE OUT AND THE BULLET (PELLET) DETACHED FROM THE SUTURE. AT THIS POINT THEY CONFIRMED THAT THERE WAS NO BULLET ON THE END OF THE SUTURE. THE BULLET (PELLET) WAS NEVER FOUND. THE PHYSICIAN CONTINUED THE CASE USING 7 ADDITIONAL SUTURES AND COMPLETED THE SURGERY SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 5591741 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120284. One submission often covers many models, so check the product and lot details in each record.

• Z-1486-2013 · May 13, 2013 · Terminated
  Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to de