CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report

FlareHawk Interbody Fusion System recalled by Integrity Implants

Integrity Implants is recalling FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions, distributed nationwide in the US. The recall was initiated on 27 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL Lots of devices are affected - IFU's are added at the time of fulfillment. FlareHawk Instructions for Use 1- IFU-0150, Rev E FlareHawk Surgical Technique Manual STM-00001, Rev A FlareHawk Surgical Technical Manual 1-STM-0336, Rev C

Quantity recalled75 sets

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0405-2019
FDA event ID: 81247
Recalling firm: Integrity Implants, Cooper City, FL
Classification: Class II
Status: Terminated
Recall initiated: 27 Feb 2018
FDA classified: 7 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

27 Feb 2018	Recall initiated by company
7 Nov 2018	Classified by FDA	+253 days
14 Nov 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.

Product as listed by the FDA

FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.

Where it was distributed

US nationwide in the states of AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA.

Nationwide Arizona California Colorado District of Columbia Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Mississippi New Jersey Nevada New York Ohio Oregon Pennsylvania Rhode Island

Questions about this recall

Why was it recalled?

Which lots are affected?

ALL Lots of devices are affected - IFU's are added at the time of fulfillment. FlareHawk Instructions for Use 1- IFU-0150, Rev E FlareHawk Surgical Technique Manual STM-00001, Rev A FlareHawk Surgical Technical Manual 1-STM-0336, Rev C

Where was it sold?

US nationwide in the states of AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integrity Implants

All 6

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29 Jan 2025Device	CLASS II	N/A Repeater Bone Tamp recalled by Integrity Implants	Integrity Implants	Device Malfunction	Nationwide
14 Dec 2022Device	CLASS II	LineSider Spinal System, Non-mod Standard - Dual Lead recalled	Integrity Implants	Other	Nationwide
14 Dec 2022Device	CLASS II	LineSider Spinal System pedicle screws, Non-mod Standard recalled	Integrity Implants	Other	5 states
14 Dec 2022Device	CLASS II	LineSider Spinal System, Non-mod MIS - Dual Lead, Cannulated recalled	Integrity Implants	Other	Nationwide
14 Dec 2022Device	CLASS II	LineSider Spinal System, Non-mod Standard - Dual Lead, Cannulated recalled	Integrity Implants	Other	Nationwide

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