FlareHawk II-1-0163Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850231007398), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 injury.

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

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 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.

• InjuryFeb 9, 2018Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE SHIM COMPONENT HAD MIGRATED POSTERIORLY. DURING THE REVISION SURGERY, THE SURGEON TAMPED THE SHIM BACK INTO PLACE AND SHIM LOCKING WAS CONFIRMED USING XRAY. IT COULD NOT BE CONFIRMED WHETHER THE SHIM HAD LOCKED DURING INITIAL IMPLANTATION. SINCE THE SHELL AND SHIM WERE LEFT IN-SITU, THEY WERE NOT RETURNED TO THE MANUFACTURER TO REVIEW FOR A DEFECT.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7258784 ↗

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