NA 462.642SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982231949), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K992348); 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.

• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANTS USED CAUSING THE PATIENT TO LOSE REDUCTION OF THE BONE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) TI SPIRAL BLADE 42MM-STERILE FOR TI HUMERAL NAILS. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 12869400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992348. One submission often covers many models, so check the product and lot details in each record.

• Z-1549-2010 · Feb 25, 2010 · Terminated
  7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fract
• Z-1548-2010 · Feb 25, 2010 · Terminated
  7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fract