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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 FlareHawk see related information
Date Initiated by Firm February 27, 2018
Create Date November 07, 2018
Recall Status1 Terminated 3 on May 06, 2019
Recall Number Z-0405-2019
Recall Event ID 81247
510(K)Number K160076  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
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
Recalling Firm/
Manufacturer		 Integrity Implants Inc.
8963 Stirling Rd Ste 8
Cooper City FL 33328-5113
For Additional Information Contact Lauren 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MAX and Original Applicant = Ouroboros Medical, Inc.
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