EXPert Nail 04.001.224SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982080882), received between May 9, 2022 and May 9, 2022 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K033071); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A HUMERAL NAIL WAS REMOVED DUE TO VARUS COLLAPSE CAUSING NAIL PROMINENCE PROXIMALLY LEADING TO PATIENT DISCOMFORT. FRACTURE HAD HEALED. IMPLANT AND EXPLANT DATES ARE UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A HUMERAL NAIL.

  Patient problems: Bone Fracture(s); Discomfort

  MAUDE report 14338298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033071. One submission often covers many models, so check the product and lot details in each record.

• Z-0407-2014 · Jul 30, 2013 · Terminated
  Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.