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.
FDA Recall Z-0405-2019 · Posted None
Recalling FirmIntegrity Implants Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2018-02-27
Date Terminated2019-05-06
Product Quantity75 sets
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.