FlareHawk II-1-0455Recalls & reported problems
Integrity Implants Inc. · Shell, Tall 27mm, Split Shim · Class 2 · Implant
All models of FlareHawk (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613020625), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Installation-Related Problem” (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
Device problems
- Installation-Related Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Installation-Related Problem; Installation-Related Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE SHIM COMPONENT HAD MIGRATED POSTERIORLY. DURING THE REVISION SURGERY THE SURGEON REMOVED THE SHIM, BUT THE SHELL COMPONENT WAS NOT REMOVED. SINCE THE SHELL WAS STABLE AND INTERVERTEBRAL HEIGHT WAS BEING MAINTAINED, THE SURGEON LEFT THE SHELL IN THE DISC SPACE AND FILLED IT WITH ADDITIONAL GRAFT. THIS SHIM WAS RETURNED TO THE MANUFACTURER AND NO DEFECTS WERE OBSERVED. POST-OPERATIVE IMAGING FROM THE ORIGINAL PROCEDURE INDICATED THAT THE SHIM COMPONENT WAS NOT LOCKED INTO THE SHELL COMPONENT AS INDICATED IN THE SURGICAL TECHNIQUE.
Patient problems: Foreign Body In Patient
MAUDE report 8465842 ↗
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 · TerminatedFlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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