BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0405-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0405-2019
    Event ID
    81247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integrity Implants Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2018
    Initiation Date
    February 27, 2018
    Classification Date
    November 7, 2018
    Termination Date
    May 6, 2019
    Address
    8963 Stirling Rd Ste 8, Cooper City, FL, 33328-5113, United States

    Description

    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.

    Reason

    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.

    Code Info

    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

    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.

    Quantity

    75 sets