BEUDAMED
    FDA Recall 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 · Initiated February 27, 2018

    Recall

    Recall Number
    Z-0405-2019
    Event Number
    81247
    Firm
    Integrity Implants Inc.
    FEI Number
    3012797630
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 27, 2018
    Terminated
    May 6, 2019
    Address
    8963 Stirling Rd, Ste 8, Cooper City, FL, 33328-5113

    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.

    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.

    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