BEUDAMED
    FDA Recall Terminated

    AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007

    Recall: Z-1562-2021 · Initiated March 29, 2021

    Recall

    Recall Number
    Z-1562-2021
    Event Number
    87677
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    FEI Number
    3001236616
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    March 29, 2021
    Terminated
    April 27, 2023
    Address
    125 May St, Ste 300, Edison, NJ, 08837-3264

    Description

    AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007

    Reason

    3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

    Action

    Musculoskeletal Transplant Foundation (MTF) issued Voluntary Field Action Notification Letter via FedX on March 29, 2021 to the Distributor. Letter states reason for recall, health risk and action to take: As the distributor. Spineology. we will need you to complete notification to your customers and provide the distribution records. questions. Please feel free to contact me at 732-661-2209. or email MTF RegulatoryAffairs at [email protected]

    Distribution

    US Nationwide distribution in the state of MN.

    Quantity

    672 units