FlareHawk II-1-0454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613020618), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K160076); 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.

• InjuryMar 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POSTERIOR MIGRATION OF THE ENTIRE CONSTRUCT APPROXIMATELY TWO YEARS LATER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11484826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160076. One submission often covers many models, so check the product and lot details in each record.

• Z-0405-2019 · Feb 27, 2018 · Terminated
  FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with