NA 04.001.008SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982080813), received between Sep 18, 2019 and Sep 18, 2019 — 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 16, 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.

• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FSLS HAD TWO (2) KITS WITH DIFFERENT SET CONFIGURATIONS. THE SET THE CONSULTANT ORDERED WAS COMPLETE WITH NO MISSING PARTS. THE CONSULTANT MUST HAVE ORDERED THE WRONG KIT.

  Patient problems: No Code Available

  MAUDE report 9082187 ↗

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.