Z-0405-2019Class II

FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only

Name: Z-0405-2019 FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only
Creator: Integrity Implants Inc.
Published: 2018-02-27
License: https://open.fda.gov/license/

Integrity Implants, Inc. / initiated 2018-02-27 / Terminated / root cause: labeling and UDI

FDA source

Integrity Implants Inc. began a recall of FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal... on 2018-02-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0405-2019
Classification: Class II
Status: Terminated
Initiated: 2018-02-27
Posted: 2018-11-07
Terminated: 2019-05-06
Recalling firm: Integrity Implants, Inc.
Product: 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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm is instructing customers to verify their inventory and return the recalled labeling material and replace them with the revised instructions and send the tracking form back to the firm.
Quantity in commerce: 75 sets
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0405-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

Product code MAX

K160076Class IIXCage™ Interbody Fusion SystemOuroboros Medical, Inc. / cleared 2016-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)