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U.S. Department of Health and Human Services

Class 2 Device Recall FlareHawk

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 Class 2 Device Recall FlareHawksee related information
Date Initiated by FirmFebruary 27, 2018
Create DateNovember 07, 2018
Recall Status1 Terminated 3 on May 06, 2019
Recall NumberZ-0405-2019
Recall Event ID 81247
510(K)NumberK160076 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductFlareHawk 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.
Code Information 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
FEI Number 3012797630
Recalling Firm/
Manufacturer		 Integrity Implants Inc.
8963 Stirling Rd Ste 8
Cooper City FL 33328-5113
For Additional Information ContactLauren Kamer
800-201-9300
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce75 sets
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MAX
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