FlareHawk II-1-0447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613020700), received between Apr 3, 2020 and Apr 3, 2020 — 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 (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.

• InjuryApr 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE SHIM COMPONENT WAS NOT LOCKED INTO THE SHELL. DURING THE REVISION SURGERY THE SURGEON REMOVED THE SHIM, BUT THE SHELL COMPONENT WAS NOT REMOVED. SINCE FUSION WAS OCCURRING THROUGH THE SHELL, THE SURGEON LEFT THE SHELL IN THE DISC SPACE AND FILLED IT WITH ADDITIONAL GRAFT. THE EXPLANTED SHELL WAS NOT RETURNED TO THE COMPANY FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9924264 ↗

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