FlareHawk II-1-0173Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850231007473), received between Apr 5, 2018 and Apr 5, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operational Issue” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K133514, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE SHIM COMPONENT HAD MIGRATED POSTERIORLY. IT COULD NOT BE CONFIRMED WHETHER THE SHIM HAD LOCKED DURING INITIAL IMPLANTATION. DURING THE REVISION SURGERY, THE SURGEON REMOVED THE SHIM FIRST, FOLLOWED BY THE SHELL. A NEW DEVICE WAS IMPLANTED, AND SHIM LOCKING WAS CONFIRMED USING XRAY. THE EXPLANTED SHELL AND SHIM WERE NOT RETURNED TO THE MANUFACTURER TO REVIEW FOR A DEFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7399632 ↗
• InjuryApr 5, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE SHIM COMPONENT HAD MIGRATED POSTERIORLY. IT COULD NOT BE CONFIRMED WHETHER THE SHIM HAD LOCKED DURING INITIAL IMPLANTATION. DURING THE REVISION SURGERY, THE SURGEON REMOVED THE SHIM FIRST, FOLLOWED BY THE SHELL. A NEW DEVICE WAS IMPLANTED, AND SHIM LOCKING WAS CONFIRMED USING XRAY. THE EXPLANTED SHELL AND SHIM WERE NOT RETURNED TO THE MANUFACTURER TO REVIEW FOR A DEFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7399631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133514, 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