BEUDAMED
    FDA Recall Open, Classified

    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

    Recall: Z-1067-2024 · Initiated December 22, 2023

    Recall

    Recall Number
    Z-1067-2024
    Event Number
    93853
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    FEI Number
    3001236616
    Product Code
    MQV
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 22, 2023
    Posted
    February 9, 2024
    Address
    125 May St, Ste 300, Edison, NJ, 08837-3264

    Description

    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

    Reason

    Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

    Action

    The firm notified their distributor of the issue during a meeting on December 22, 2023. A notification letter was also issued to the distributor. If the device/tissue was transplanted, no further action is warranted. However, if the device/tissue is still available in the customer's inventory, the unit shall be returned to Spineology, the distributor. Should you have any questions, please contact the firm at 732-661-2209, or email MTF Regulatory Affairs at [email protected].

    Distribution

    Product was distributed to Minnesota.

    Quantity

    50